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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/NCT03572062
Registration number
NCT03572062
Ethics application status
Date submitted
1/06/2018
Date registered
28/06/2018
Date last updated
26/08/2021
Titles & IDs
Public title
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
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Scientific title
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS
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Secondary ID [1]
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RSV ADJUVANT
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Secondary ID [2]
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C3671002
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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 - Formulation A
Other interventions - Formulation B
Other interventions - Formulation C
Other interventions - Placebo
Experimental: Arm 1 - Low dose formulation A and SIIV
Experimental: Arm 2 - Low dose formulation B and SIIV
Experimental: Arm 3 - Mid dose formulation A and SIIV
Experimental: Arm 4 - Mid dose formulation B and SIIV
Experimental: Arm 5 - High dose formulation A and SIIV
Experimental: Arm 6 - High dose formulation B and SIIV
Experimental: Arm 7 - High dose formulation C and SIIV
Placebo Comparator: Arm 8 - Placebo and SIIV
Experimental: M0M2 Arm 1 - High dose formulation B
Placebo Comparator: M0M2 Arm 2 - Placebo
Other interventions: Formulation A
RSV vaccine
Other interventions: Formulation B
Adjuvanted RSV vaccine
Other interventions: Formulation C
RSV vaccine
Other interventions: Placebo
Placebo
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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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Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
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Assessment method [1]
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Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than [>] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than [>] 5.0 to 10.0 cm), and severe (>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).
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Timepoint [1]
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Within 14 days after Vaccination 1
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Primary outcome [2]
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Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
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Assessment method [2]
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Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees [deg] Celsius [C]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle 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 (1-2 times in 24 hours [h]), moderate (>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).
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Timepoint [2]
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Within 14 days after Vaccination 1
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Primary outcome [3]
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Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
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Assessment method [3]
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An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.
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Timepoint [3]
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Within 1 month after Vaccination 1
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Primary outcome [4]
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Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
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Assessment method [4]
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An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
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Timepoint [4]
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Up to 12 months after Vaccination 1
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Secondary outcome [1]
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Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
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Assessment method [1]
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GMTs of RSV A and RSV B antigens were measured using neutralizing assay. Titers above the lower limit of quantitation (LLOQ) were considered accurate and their quantitated values were reported. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5 × LLOQ.
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Timepoint [1]
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Before vaccination and 1 Month after Vaccination 1
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Secondary outcome [2]
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Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
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Assessment method [2]
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The HAI and neutralizing titer LLOQ value for each strain was 1:10. Assay results below the LLOQ were set to 0.5 × LLOQ. The analysis was performed on following strains: H1N1 A/Michigan, H3N2 A/Brisbane, B/Phuket for HAI and H3N2/Brisbane for neutralizing assay.
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Timepoint [2]
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Before vaccination and 1 Month after Vaccination 1
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Eligibility
Key inclusion criteria
1. Evidence of a personally signed and dated informed consent document (ICD) indicating
that the subject has been informed of all pertinent aspects of the study.
2. Healthy adults who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study.
3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests,
and other study procedures.
4. Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of
enrollment (signing of the ICD).
5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit
1 and have signed and dated the ICD for participating in the revaccination stage
(applies to Primary Study Cohort - Stage 2 subjects).
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Minimum age
65
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
subjects who are Pfizer employees, including their family members, directly involved
in the conduct of the study.
2. Participation in other studies involving investigational product within 28 days prior
to study entry and/or during study participation.
3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
4. Previous vaccination with any licensed or investigational RSV vaccine before
enrollment into the study, or planned receipt throughout the study of nonstudy RSV
vaccine.
5. Vaccination with any influenza vaccine within 6 months (182 days) before
investigational product administration (applies to Primary Study Cohort - Stages 1 and
2).
6. History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the investigational product(s),
including natural rubber latex. In addition, a history of severe allergic reaction
(eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg
or egg products) or chicken proteins.
7. Subjects with known or suspected immunodeficiency, as determined by history and/or
laboratory/physical examination.
8. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic
agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
planned receipt throughout the study. If systemic corticosteroids have been
administered short term (<14 days) for treatment of an acute illness, subjects should
not be enrolled into the study until corticosteroid therapy has been discontinued for
at least 28 days before investigational product administration.Inhaled/nebulized,
intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are
permitted.
9. Subject 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 syndrome, idiopathic thrombocytopenic purpura,
autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal
arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
10. Receipt of blood/plasma products or immunoglobulin, from 60 days before
investigational product administration or planned receipt throughout the study.
11. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
12. Female subjects of childbearing potential or who are pregnant or breastfeeding;
fertile male subjects who are unwilling to use a highly effective method of
contraception for at least 28 days after the last dose of investigational product.
13. 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 subject inappropriate for entry into this
study.
14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after
Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).
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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
Terminated
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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
5/06/2018
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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
19/08/2020
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Sample size
Target
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Accrual to date
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Final
317
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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AIM Centre (Hunter Diabetes Centre) - Merewether
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Recruitment hospital [3]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [4]
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Westmead Hospital (Infectious Diseases and Microbiology) - Westmead
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Recruitment hospital [5]
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Data Health Australia Pty Limited (Trading as AusTrials) - Taringa
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Recruitment hospital [6]
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Eastern Health - Box Hill
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Recruitment hospital [7]
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Emeritus Research Pty. Ltd. - Camberwell
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Recruitment hospital [8]
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Monash Medical Centre - Clayton
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Recruitment hospital [9]
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Barwon Health - Geelong
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Recruitment hospital [10]
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Doctors of Ivanhoe - Ivanhoe
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Recruitment hospital [11]
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Institute for Respiratory Health - Nedlands
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Recruitment hospital [12]
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TrialsWest - Spearwood
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2291 - Merewether
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4068 - Taringa
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3124 - Camberwell
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment postcode(s) [10]
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3079 - Ivanhoe
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment postcode(s) [12]
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6163 - Spearwood
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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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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Nebraska
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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
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV
vaccine candidates, some with adjuvant, when administered concomitantly with seasonal
inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine
administered12 months after the initial dose.
In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62
subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03572062
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03572062
Download to PDF