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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/NCT04032093
Registration number
NCT04032093
Ethics application status
Date submitted
22/07/2019
Date registered
25/07/2019
Date last updated
18/10/2022
Titles & IDs
Public title
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
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Scientific title
A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
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Secondary ID [1]
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C3671003
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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:
Respiratory Tract Infection
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSV vaccine
Other interventions - Placebo
Experimental: RSV dose with aluminum hydroxide - RSV vaccine with aluminum hydroxide
Experimental: RSV dose without aluminum hydroxide - RSV vaccine without aluminum hydroxide
Experimental: Higher RSV dose with aluminum hydroxide - Higher dose level RSV vaccine with aluminum hydroxide
Experimental: Higher RSV dose without aluminum hydroxide - Higher dose level RSV vaccine without aluminum hydroxide
Placebo Comparator: Placebo dose - Normal saline solution for injection (0.9% sodium chloride injection)
Other interventions: RSV vaccine
RSV vaccine
Other interventions: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)
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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 Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
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Assessment method [1]
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Local reactions included pain at injection site, redness and swelling and were recorded by 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) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
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Timepoint [1]
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Within 7 days after vaccination
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Primary outcome [2]
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Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
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Assessment method [2]
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Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (>=38.0 to 38.4 degrees [deg] Celsius [C]), grade 2: moderate (>38.4 to 38.9 deg C), grade 3: severe (>38.9 to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
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Timepoint [2]
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Within 7 days after vaccination
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Primary outcome [3]
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Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
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Assessment method [3]
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An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
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Timepoint [3]
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Within 1 month after vaccination
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Primary outcome [4]
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Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
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Assessment method [4]
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MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
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Timepoint [4]
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From day of vaccination (Day 1) up to 12 months post-delivery
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Primary outcome [5]
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Percentage of Infant Participants With Specific Birth Complications
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Assessment method [5]
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Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
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Timepoint [5]
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At birth
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Primary outcome [6]
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Percentage of Infant Participants With Any AE Within 1 Month of Age
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Assessment method [6]
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An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
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Timepoint [6]
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Within 1 month after birth
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Primary outcome [7]
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Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
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Assessment method [7]
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MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
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Timepoint [7]
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Within 12 months after birth
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Primary outcome [8]
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Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
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Assessment method [8]
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AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
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Timepoint [8]
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Within 12 months after birth
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Secondary outcome [1]
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Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
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Assessment method [1]
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GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
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Timepoint [1]
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Before vaccination, 2 weeks and 1 month after vaccination and at delivery
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Secondary outcome [2]
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Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
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Assessment method [2]
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GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.
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Timepoint [2]
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2 weeks and 1 month after vaccination, at delivery
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Secondary outcome [3]
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Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
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Assessment method [3]
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GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
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Timepoint [3]
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At birth and at 1, 2, 4, 6 months after birth
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Eligibility
Key inclusion criteria
Inclusion Criteria - Maternal participants:
- Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of
planned vaccination, with an uncomplicated pregnancy, who are at no known increased
risk for complications, and whose fetus has no significant abnormalities observed on
ultrasound.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.
- Receiving prenatal standard of care.
- Had an ultrasound performed at >=18 weeks of pregnancy.
- Had a negative urinalysis for protein and glucose at the screening visit. Trace
protein in the urine is acceptable if the blood pressure is also normal.
- Determined by medical history, physical examination, screening laboratory assessment,
and clinical judgment to be appropriate for inclusion in the study.
- Documented negative human immunodeficiency virus antibody, hepatitis B virus surface
antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
- Body mass index of </=40 kg/m2 at the time of the screening visit.
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent document and in this
protocol.
- Expected to be available for the duration of the study and willing to give informed
consent for her infant to participate in the study.
Inclusion Criteria - Infant Participants:
- Evidence of a signed and dated ICD signed by the parent(s).
- Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures.
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Minimum age
18
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Maximum age
49
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria - Maternal Participants:
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction to any component of the investigational product or any related vaccine.
- History of latex allergy.
- History of any severe allergic reaction.
- Participants with known or suspected immunodeficiency.
- Current pregnancy resulting from in vitro fertilization or other assisted reproductive
technology.
- A prior history of or known current pregnancy complications or abnormalities that will
increase the risk associated with the participant's participation in and completion of
the study.
- Major illness of the mother or conditions of the fetus that, in the investigator's
judgment, will substantially increase the risk associated with the participant's
participation in, and completion of, the study or could preclude the evaluation of the
participant's response.
- Participant with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention including but not limited to systemic or cutaneous
lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré
syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis),
psoriasis, and insulin-dependent diabetes mellitus (type 1).
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior 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.
- Participation in other studies involving investigational drug(s) within 28 days prior
to study entry and/or during study participation.
- Participants who receive treatment with immunosuppressive therapy including cytotoxic
agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or
planned receipt of such treatment or agents during study participation. If systemic
corticosteroids have been administered short term (<14 days) for treatment of an acute
illness, participants should not be enrolled into the study until corticosteroid
therapy has been discontinued for at least 30 days before investigational product
administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or
eyes) corticosteroids are permitted.
- Current alcohol abuse or illicit drug use.
- Receipt of blood or plasma products or immunoglobulin, from 60 days before
investigational product administration, or planned receipt through delivery, with 1
exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
- Previous vaccination with any licensed or investigational RSV vaccine or planned
receipt during study participation.
- Laboratory test results at the screening visit outside the normal reference value for
pregnant women according to their trimester in pregnancy.
- Participants who are breastfeeding at the time of the screening visit.
Exclusion Criteria - Infant Participants:
• Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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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)
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Masking / blinding
Blinded (masking used)
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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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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2021
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Sample size
Target
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Accrual to date
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Final
1153
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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Georgia
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Idaho
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Iowa
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Kansas
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Louisiana
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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New Mexico
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New York
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North Carolina
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Ohio
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South Carolina
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Texas
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Utah
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Virginia
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West Virginia
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Argentina
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Tucuman
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Chile
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Region Metropolitana
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Chile
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Región DE LOS Lagos
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Chile
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Chile
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RM
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New Zealand
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Christchurch
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South Africa
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Gauteng
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV
vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine,
formulated with or without aluminum hydroxide, or placebo, and investigate safety and
characteristics of antibodies in their infants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04032093
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04032093
Download to PDF