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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04546425
Registration number
NCT04546425
Ethics application status
Date submitted
21/08/2020
Date registered
14/09/2020
Date last updated
8/01/2024
Titles & IDs
Public title
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
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Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
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Secondary ID [1]
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2019-003306-27
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Secondary ID [2]
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B7471012
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Disease
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 20-valent pneumococcal conjugate vaccine
Other interventions - 13-valent pneumococcal conjugate vaccine
Experimental: 20-valent pneumococcal conjugate vaccine - Pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine - Pneumococcal conjugate vaccine
Other interventions: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Other interventions: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
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Assessment method [1]
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Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
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Timepoint [1]
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Within 7 days after Dose 1
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Primary outcome [2]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
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Assessment method [2]
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Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
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Timepoint [2]
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Within 7 days after Dose 2
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Primary outcome [3]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
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Assessment method [3]
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Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
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Timepoint [3]
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Within 7 days after Dose 3
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Primary outcome [4]
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Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
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Assessment method [4]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
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Timepoint [4]
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Within 7 Days after Dose 1
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Primary outcome [5]
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Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
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Assessment method [5]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
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Timepoint [5]
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Within 7 Days after Dose 2
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Primary outcome [6]
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Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
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Assessment method [6]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) & severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
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Timepoint [6]
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Within 7 Days after Dose 3
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Primary outcome [7]
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Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population
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Assessment method [7]
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
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Timepoint [7]
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From Dose 1 to 1 month after Dose 2
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Primary outcome [8]
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Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population
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Assessment method [8]
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
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Timepoint [8]
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From Dose 3 to 1 month after Dose 3
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Primary outcome [9]
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Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population
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Assessment method [9]
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A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
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Timepoint [9]
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From Dose 1 to 1 month after Dose 3
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Primary outcome [10]
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Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population
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Assessment method [10]
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A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
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Timepoint [10]
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From Dose 1 to 1 month after Dose 3
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Primary outcome [11]
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Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
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Assessment method [11]
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Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
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Timepoint [11]
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1 month after Dose 2
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Primary outcome [12]
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
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Assessment method [12]
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Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
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Timepoint [12]
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1 month after Dose 2
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Primary outcome [13]
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GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [13]
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Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
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Timepoint [13]
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1 month after Dose 3
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Primary outcome [14]
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Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
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Assessment method [14]
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Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units [IU]) to diphtheria & tetanus toxoid (prespecified level>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level >=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level >=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: >=1:8; Hemophilus influenzae type b(Hib): prespecified level >=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.
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Timepoint [14]
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1 month after Dose 3
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Primary outcome [15]
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GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [15]
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Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
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Timepoint [15]
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1 month after Dose 3
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Primary outcome [16]
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GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [16]
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Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
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Timepoint [16]
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1 month after Dose 3
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Primary outcome [17]
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GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [17]
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Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
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Timepoint [17]
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1 month after Dose 3
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Primary outcome [18]
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GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [18]
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Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
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Timepoint [18]
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1 month after Dose 3
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Primary outcome [19]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
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Assessment method [19]
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Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
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Timepoint [19]
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Within 7 days after Dose 1
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Primary outcome [20]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
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Assessment method [20]
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Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
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Timepoint [20]
0
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Within 7 days after Dose 2
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Primary outcome [21]
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Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
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Assessment method [21]
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0
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
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Timepoint [21]
0
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Within 7 days after Dose 3
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Primary outcome [22]
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Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
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Assessment method [22]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature >=38.0 degree C & categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
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Timepoint [22]
0
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Within 7 Days after Dose 1
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Primary outcome [23]
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Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
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Assessment method [23]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
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Timepoint [23]
0
0
Within 7 Days after Dose 2
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Primary outcome [24]
0
0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
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Assessment method [24]
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Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
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Timepoint [24]
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0
Within 7 Days after Dose 3
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Primary outcome [25]
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Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort
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Assessment method [25]
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
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Timepoint [25]
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0
From Dose 1 to 1 month after Dose 2
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Primary outcome [26]
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0
Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort
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Assessment method [26]
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0
An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
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Timepoint [26]
0
0
From Dose 3 to 1 month after Dose 3
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Primary outcome [27]
0
0
Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort
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Assessment method [27]
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0
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
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Timepoint [27]
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0
From Dose 1 to 1 month after Dose 3
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Primary outcome [28]
0
0
Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort
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Assessment method [28]
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A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
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Timepoint [28]
0
0
From Dose 1 to 1 month after Dose 3
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Primary outcome [29]
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0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
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Assessment method [29]
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0
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B. >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
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Timepoint [29]
0
0
1 month after Dose 2
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Primary outcome [30]
0
0
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
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Assessment method [30]
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0
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
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Timepoint [30]
0
0
1 month after Dose 2
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Primary outcome [31]
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0
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
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Assessment method [31]
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0
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Query!
Timepoint [31]
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0
1 month after Dose 3
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Secondary outcome [1]
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0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
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Assessment method [1]
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0
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Query!
Timepoint [1]
0
0
1 Month after Dose 3
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Secondary outcome [2]
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0
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
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Assessment method [2]
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0
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
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Timepoint [2]
0
0
1 month after Dose 2
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Secondary outcome [3]
0
0
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
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Assessment method [3]
0
0
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Query!
Timepoint [3]
0
0
1 Month after Dose 3
Query!
Secondary outcome [4]
0
0
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Query!
Assessment method [4]
0
0
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Query!
Timepoint [4]
0
0
Before Dose 3 to 1 month after Dose 3
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Secondary outcome [5]
0
0
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Query!
Assessment method [5]
0
0
Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units [IU]) to diphtheria and tetanus toxoid (prespecified level >= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.
Query!
Timepoint [5]
0
0
1 month after Dose 2
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Query!
Assessment method [6]
0
0
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Query!
Timepoint [6]
0
0
1 Month after Dose 3
Query!
Secondary outcome [7]
0
0
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Query!
Assessment method [7]
0
0
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
Query!
Timepoint [7]
0
0
1 month after Dose 2
Query!
Secondary outcome [8]
0
0
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Query!
Assessment method [8]
0
0
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
Query!
Timepoint [8]
0
0
1 Month after Dose 3
Query!
Eligibility
Key inclusion criteria
- Male or female infants born at >36 weeks of gestation and 2 months of age at the time
of consent.
- Healthy infants determined by clinical assessment, including medical history and
clinical judgment, to be eligible for the study.
Query!
Minimum age
42
Days
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Query!
Maximum age
112
Days
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.
Query!
Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
9/09/2020
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/02/2023
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Sample size
Target
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Accrual to date
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Final
1258
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
0
0
Perth Children's Hospital - Nedlands
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Recruitment hospital [2]
0
0
Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
Belgium
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State/province [1]
0
0
Brussels
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Edegem
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Country [3]
0
0
Czechia
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State/province [3]
0
0
Jindrichuv Hradec
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Country [4]
0
0
Czechia
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State/province [4]
0
0
Pardubice
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Country [5]
0
0
Czechia
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State/province [5]
0
0
Praha 3
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Country [6]
0
0
Czechia
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State/province [6]
0
0
Praha 6
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Country [7]
0
0
Denmark
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State/province [7]
0
0
Hvidovre
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Country [8]
0
0
Estonia
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State/province [8]
0
0
Kadrina
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Country [9]
0
0
Estonia
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State/province [9]
0
0
Tallinn
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Country [10]
0
0
Estonia
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State/province [10]
0
0
Tartu
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Country [11]
0
0
Finland
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State/province [11]
0
0
Espoo
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Country [12]
0
0
Finland
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State/province [12]
0
0
Helsinki
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Country [13]
0
0
Finland
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State/province [13]
0
0
Jarvenpaa
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Country [14]
0
0
Finland
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State/province [14]
0
0
Kokkola
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Country [15]
0
0
Finland
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State/province [15]
0
0
Oulu
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Country [16]
0
0
Finland
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State/province [16]
0
0
Pori
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Country [17]
0
0
Finland
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State/province [17]
0
0
Seinajoki
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Country [18]
0
0
Finland
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State/province [18]
0
0
Tampere
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Country [19]
0
0
Finland
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State/province [19]
0
0
Turku
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Country [20]
0
0
Italy
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State/province [20]
0
0
Milan
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Country [21]
0
0
Italy
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State/province [21]
0
0
Firenze
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Country [22]
0
0
Italy
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State/province [22]
0
0
Foggia
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Country [23]
0
0
Italy
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State/province [23]
0
0
Genova
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Country [24]
0
0
Netherlands
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State/province [24]
0
0
Haarlem
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Country [25]
0
0
Netherlands
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State/province [25]
0
0
Hoofddorp
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Country [26]
0
0
Norway
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State/province [26]
0
0
Lorenskog
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Country [27]
0
0
Norway
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State/province [27]
0
0
Oslo
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Country [28]
0
0
Norway
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State/province [28]
0
0
Stavanger
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Country [29]
0
0
Norway
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State/province [29]
0
0
Viken
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Country [30]
0
0
Poland
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State/province [30]
0
0
Bydgoszcz
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Country [31]
0
0
Poland
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State/province [31]
0
0
Debica
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Country [32]
0
0
Poland
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State/province [32]
0
0
Krakow
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Country [33]
0
0
Poland
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State/province [33]
0
0
Leczna
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Country [34]
0
0
Poland
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State/province [34]
0
0
Lodz
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Country [35]
0
0
Poland
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State/province [35]
0
0
Lubon
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Country [36]
0
0
Poland
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State/province [36]
0
0
Poznan
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Country [37]
0
0
Poland
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State/province [37]
0
0
Siemianowice Slaskie
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Country [38]
0
0
Poland
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State/province [38]
0
0
Torun
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Country [39]
0
0
Poland
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State/province [39]
0
0
Trzebnica
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Country [40]
0
0
Poland
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State/province [40]
0
0
Warszawa
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Country [41]
0
0
Poland
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State/province [41]
0
0
Wroclaw
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Country [42]
0
0
Russian Federation
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State/province [42]
0
0
Ekaterinburg
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Country [43]
0
0
Russian Federation
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State/province [43]
0
0
Moscow
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Country [44]
0
0
Russian Federation
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State/province [44]
0
0
Perm
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Country [45]
0
0
Russian Federation
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State/province [45]
0
0
Saint Petersburg
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Country [46]
0
0
Slovakia
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State/province [46]
0
0
Bratislava
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Country [47]
0
0
Slovakia
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State/province [47]
0
0
Detva
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Country [48]
0
0
Slovakia
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State/province [48]
0
0
Horne Srnie
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Country [49]
0
0
Slovakia
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State/province [49]
0
0
Humenne
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Country [50]
0
0
Slovakia
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State/province [50]
0
0
Kosice
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Country [51]
0
0
Slovakia
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State/province [51]
0
0
Liptovská Osada
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series
in Healthy Infants
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04546425
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04546425
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