Respiratory Tract InfectionsPhase 2NCT03529773

A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

A Phase 2 study testing Formulation A and Formulation B in people with Respiratory Tract Infections, run by Pfizer at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV). Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Tract Infections
What is being tested?: Formulation A and Formulation B
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,235 participants
Where: 40 sitesUnited States
Study dates: 18 Apr 2018to 28 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).

Who cannot join

Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
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.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.

Show all 16Show fewer

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
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's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
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.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Augusta Family Practice
Augusta, Kansas, 67010
Heartland Research Associates, LLC
Augusta, Kansas, 67010
Benchmark Research
Austin, Texas, 78705
United Medical Associates
Binghamton, New York, 13901
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
Aventiv Research Inc.
Columbus, Ohio, 43213
Clinical Research of South Florida
Coral Gables, Florida, 33134
PriMed Clinical Research
Dayton, Ohio, 45419
Regional Clinical Research, Inc.
Endwell, New York, 13760
Texas Health Care, PLLC
Fort Worth, Texas, 76104
Ventavia Research Group, LLC
Fort Worth, Texas, 76104
Benchmark Research
Fort Worth, Texas, 76135
HealthFirst Medical Group
Fort Worth, Texas, 76135
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Paradigm Clinical Research Centers, Inc.
La Mesa, California, 91942
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Axtell Clinic, P.A.
Newton, Kansas, 67114
Heartland Research Associates, LLC
Newton, Kansas, 67114
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
PMG Research of Raleigh
Raleigh, North Carolina, 27609
Paradigm Clinical Research Center
Redding, California, 96001
Rochester Regional Health/Rochester General Hospital
Rochester, New York, 14621
University of Rochester Medical Center
Rochester, New York, 14642
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City, Utah, 84121
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Meridian Clinical Research
Savannah, Georgia, 31406
Meridian Clinical Research Dakota Dunes
Sioux City, Iowa, 51106
J.Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Advanced Clinical Research
West Jordan, Utah, 84088
Heartland Research Associates, LLC
Wichita, Kansas, 67207
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Read the detailed description

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.

Conditions: Respiratory Tract Infections
Being tested: Formulation A, Formulation B, Placebo
Keywords: Respiratory tract infections, RSV, vaccine
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Formulation ABiological
RSV vaccine
Formulation BBiological
RSV vaccine
PlaceboBiological
Placebo

Study groups in NCT03529773
Study group	Role	What they receive
Sentinel Arm 1	Experimental	Low dose formulation A Receives: Biological: Formulation A
Sentinel Arm 2	Experimental	Mid dose formulation A Receives: Biological: Formulation A
Sentinel Arm 3	Experimental	High dose formulation A Receives: Biological: Formulation A
Sentinel Arm 4	Experimental	Low dose formulation B Receives: Biological: Formulation B
Sentinel Arm 5	Experimental	Mid dose formulation B Receives: Biological: Formulation B
Sentinel Arm 6	Experimental	High dose formulation B Receives: Biological: Formulation B
Sentinel Arm 7	Placebo comparator	Placebo Receives: Biological: Placebo
Expanded Arm 8	Experimental	Low dose formulation A and SIIV Receives: Biological: Formulation A
Expanded Arm 9	Experimental	Mid dose formulation A and SIIV Receives: Biological: Formulation A
Expanded Arm 10	Experimental	High dose formulation A and SIIV Receives: Biological: Formulation A
Expanded Arm 11	Experimental	Low dose formulation B and SIIV Receives: Biological: Formulation B
Expanded Arm 12	Experimental	Mid dose formulation B and SIIV Receives: Biological: Formulation B
Expanded Arm 13	Experimental	High dose formulation B and SIIV Receives: Biological: Formulation B
Expanded Arm 14	Experimental	Low dose formulation A and placebo Receives: Biological: Formulation A
Expanded Arm 15	Experimental	Mid dose formulation A and placebo Receives: Biological: Formulation A
Expanded Arm 16	Experimental	High dose formulation A and placebo Receives: Biological: Formulation A
Expanded Arm 17	Experimental	Low dose formulation B and placebo Receives: Biological: Formulation B
Expanded Arm 18	Experimental	Mid dose formulation B and placebo Receives: Biological: Formulation B
Expanded Arm 19	Experimental	High dose formulation B and placebo Receives: Biological: Formulation B
Expanded Arm 20	Placebo comparator	placebo and placebo Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling 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: 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 daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Measured: Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 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.
Measured: Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Measured: Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 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.
Measured: Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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: requires 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.
Measured: Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Measured: Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Measured: Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Measured: Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
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.
Measured: Within 1 month after vaccination (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
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.
Measured: Within 1 month after vaccination (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
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.
Measured: Within 1 month after vaccination 1 (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
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.
Measured: Within 1 month after vaccination 1 (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted 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.
Measured: Upto 12 months after vaccination (up to 378 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted 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.
Measured: Upto 12 months after vaccination (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted 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.
Measured: Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted 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.
Measured: Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
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.
Measured: Within 1 month after vaccination 2 (upto Day 70)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
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.
Measured: Within 1 month after vaccination 2 (upto Day 70)

Secondary outcomes (6)

Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination and 1 Month after SIIV vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Measured: Before vaccination and 1 Month after SIIV vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201828 Dec 2020

First posted18 May 2018
Study start18 Apr 2018
Primary completion20 Nov 2019
Study completion28 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03529773
Sponsor's protocol ID: C3671001
Other IDs: RSV FIH
Status last verified: Mar 2022
First submitted: 17 Apr 2018
Last updated: 3 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Walsh EE, Falsey AR, Zareba AM, Jiang Q, Gurtman A, Radley D, Gomme E, Cooper D, Jansen KU, Gruber WC, Swanson KA, Schmoele-Thoma B. Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.
PubMed 38606958
Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.
PubMed 34932102
Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.
PubMed 34931667

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS
ClinicalTrials.gov ID: NCT03529773
Acronym / sponsor ID: C3671001
Conditions: Respiratory Tract Infections
Keywords: Respiratory tract infections, RSV, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,235 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 18 Apr 2018 (actual)
Primary completion: 20 Nov 2019 (actual)
Study completion: 28 Dec 2020 (actual)
First posted: 18 May 2018 (actual)
Results: Posted 4 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 20
Model description: Parallel

Arm	Type	Receives
Sentinel Arm 1	Experimental	Biological: Formulation ALow dose formulation A
Sentinel Arm 2	Experimental	Biological: Formulation AMid dose formulation A
Sentinel Arm 3	Experimental	Biological: Formulation AHigh dose formulation A
Sentinel Arm 4	Experimental	Biological: Formulation BLow dose formulation B
Sentinel Arm 5	Experimental	Biological: Formulation BMid dose formulation B
Sentinel Arm 6	Experimental	Biological: Formulation BHigh dose formulation B
Sentinel Arm 7	Placebo comparator	Biological: PlaceboPlacebo
Expanded Arm 8	Experimental	Biological: Formulation ALow dose formulation A and SIIV
Expanded Arm 9	Experimental	Biological: Formulation AMid dose formulation A and SIIV
Expanded Arm 10	Experimental	Biological: Formulation AHigh dose formulation A and SIIV
Expanded Arm 11	Experimental	Biological: Formulation BLow dose formulation B and SIIV
Expanded Arm 12	Experimental	Biological: Formulation BMid dose formulation B and SIIV
Expanded Arm 13	Experimental	Biological: Formulation BHigh dose formulation B and SIIV
Expanded Arm 14	Experimental	Biological: Formulation ALow dose formulation A and placebo
Expanded Arm 15	Experimental	Biological: Formulation AMid dose formulation A and placebo
Expanded Arm 16	Experimental	Biological: Formulation AHigh dose formulation A and placebo
Expanded Arm 17	Experimental	Biological: Formulation BLow dose formulation B and placebo
Expanded Arm 18	Experimental	Biological: Formulation BMid dose formulation B and placebo
Expanded Arm 19	Experimental	Biological: Formulation BHigh dose formulation B and placebo
Expanded Arm 20	Placebo comparator	Biological: Placeboplacebo and placebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).

Key exclusion criteria (16 listed)

Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
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.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Formulation ARSV vaccine	Biological	Expanded Arm 10, Expanded Arm 14, Expanded Arm 15, Expanded Arm 16, Expanded Arm 8, Expanded Arm 9, Sentinel Arm 1, Sentinel Arm 2, Sentinel Arm 3
Formulation BRSV vaccine	Biological	Expanded Arm 11, Expanded Arm 12, Expanded Arm 13, Expanded Arm 17, Expanded Arm 18, Expanded Arm 19, Sentinel Arm 4, Sentinel Arm 5, Sentinel Arm 6
PlaceboPlacebo	Biological	Expanded Arm 20, Sentinel Arm 7

Primary outcome

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Local reactions included pain at injection site, redness and swelling 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: 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 daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 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.
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Time frame: Within 14 days after vaccination 1 on Day 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Time frame: Within 14 days after vaccination 1 on Day 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 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.
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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: requires 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.
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Time frame: Within 14 days after vaccination 1 on Day 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Time frame: Within 14 days after vaccination 1 on Day 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C 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 h, moderate: >2 times in 24h and severe: requires 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.
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: Within 1 month after vaccination (up to 35 days)
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.
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
Time frame: Within 1 month after vaccination (up to 35 days)
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.
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
Time frame: Within 1 month after vaccination 1 (up to 35 days)
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.
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
Time frame: Within 1 month after vaccination 1 (up to 35 days)
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.
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
Time frame: Upto 12 months after vaccination (up to 378 days)
MAE was defined as a non-serious AE that resulted 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.
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
Time frame: Upto 12 months after vaccination (upto 378 days)
MAE was defined as a non-serious AE that resulted 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.
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
Time frame: Upto 12 months after vaccination 1 (upto 378 days)
MAE was defined as a non-serious AE that resulted 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.
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
Time frame: Upto 12 months after vaccination 1 (upto 378 days)
MAE was defined as a non-serious AE that resulted 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.
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
Time frame: Within 1 month after vaccination 2 (upto Day 70)
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.
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
Time frame: Within 1 month after vaccination 2 (upto Day 70)
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.

6 secondary outcomes

Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Time frame: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
Time frame: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Time frame: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
Time frame: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
Time frame: Before vaccination and 1 Month after SIIV vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
Time frame: Before vaccination and 1 Month after SIIV vaccination

Results and safety

Results posted to the registry on 4 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sentinel Cohort: Respiratory Syncytial Virus (RSV) Vaccine 60 Microgram (mcg) Age 18-49 Years	12	12
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	12	12
Sentinel Cohort: RSV 120 mcg Age 18-49 Years	12	11
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	12	12
Sentinel Cohort: RSV 240 mcg Age 18-49 Years	12	11
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	12	11
Sentinel Cohort: Placebo Age 18-49 Years	12	12
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	12	11
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	12	12
Sentinel Cohort: RSV 120 mcg Age 50-85 Years	12	11
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	12	11
Sentinel Cohort: RSV 240 mcg Age 50-85 Years	12	12
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	12	10
Sentinel Cohort: Placebo Age 50-85 Years	12	11
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	41	35
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	42	38
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	41	40
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	41	35
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	41	37
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	41	37
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	41	34
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	41	36
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	41	34
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	41	35
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	41	33
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	41	30
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	41	32
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	41	39
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	41	40
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	40	40
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	42	39
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	40	40
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	40	40
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	41	39
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	41	37
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	40	36
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	41	39
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	42	36
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	43	39
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years	41	37

Primary outcome: Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years n = 12	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years n = 12	Sentinel Cohort: RSV 120 mcg Age 18-49 Years n = 12	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years n = 12	Sentinel Cohort: RSV 240 mcg Age 18-49 Years n = 11	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years n = 12	Sentinel Cohort: Placebo Age 18-49 Years n = 12
Pain at injection site: mild	50.0 (21.1 to 78.9)	58.3 (27.7 to 84.8)	25.0 (5.5 to 57.2)	75.0 (42.8 to 94.5)	0 (0.0 to 28.5)	58.3 (27.7 to 84.8)	16.7 (2.1 to 48.4)
Pain at injection site: moderate	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	18.2 (2.3 to 51.8)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)

Primary outcome: Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years n = 12	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years n = 12	Sentinel Cohort: RSV 120 mcg Age 50-85 Years n = 12	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years n = 12	Sentinel Cohort: RSV 240 mcg Age 50-85 Years n = 12	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years n = 12	Sentinel Cohort: Placebo Age 50-85 Years n = 12
Pain at injection site: mild	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: moderate	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: mild	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)

Primary outcome: Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1

Time frame: Within 14 days after vaccination 1 on Day 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years n = 42	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years n = 40	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years n = 41	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years n = 40	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years n = 41	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years n = 41	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years n = 41	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years n = 41
Pain at injection site: mild	34.1 (20.1 to 50.6)	31.0 (17.6 to 47.1)	41.5 (26.3 to 57.9)	32.5 (18.6 to 49.1)	36.6 (22.1 to 53.1)	43.9 (28.5 to 60.3)	48.8 (32.9 to 64.9)	55.0 (38.5 to 70.7)	24.4 (12.4 to 40.3)	34.1 (20.1 to 50.6)	51.2 (35.1 to 67.1)	48.8 (32.9 to 64.9)	14.6 (5.6 to 29.2)
Pain at injection site: moderate	12.2 (4.1 to 26.2)	7.1 (1.5 to 19.5)	26.8 (14.2 to 42.9)	20.0 (9.1 to 35.6)	9.8 (2.7 to 23.1)

Primary outcome: Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1

Time frame: Within 14 days after vaccination 1 on Day 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years n = 40	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years n = 40	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years n = 40	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years n = 42	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years n = 40	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years n = 40	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years n = 41	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years n = 41	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years n = 40	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years n = 41	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years n = 42	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years n = 43	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years n = 40
Pain at injection site: mild	25.0 (12.7 to 41.2)	10.0 (2.8 to 23.7)	22.5 (10.8 to 38.5)	23.8 (12.1 to 39.5)	22.5 (10.8 to 38.5)	10.0 (2.8 to 23.7)	26.8 (14.2 to 42.9)	19.5 (8.8 to 34.9)	32.5 (18.6 to 49.1)	19.5 (8.8 to 34.9)	19.0 (8.6 to 34.1)	14.0 (5.3 to 27.9)	5.0 (0.6 to 16.9)
Pain at injection site: moderate	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	5.0 (0.6 to 16.9)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions and systemic events collected as Non-SAEs: within 14 days after Vaccination (Vax) 1 and Vax 3 (for revaccination); Other Non-SAEs: Vax 1 up to 1 month after Vax 1, Vax 3 up to 1 month after Vax 3 for revaccination; SAEs: Vax 1 up to 12 months after Vax 1 (approximately up to 378 days), Vax 1 up to 12 months after Vax 3 for revaccination (approximately up to 798 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Sentinel Cohort: RSV 120 mcg Age 18-49 Years	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Sentinel Cohort: RSV 240 mcg Age 18-49 Years	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Sentinel Cohort: Placebo Age 18-49 Years	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	2 of 12 (16.7%)	8 of 12 (66.7%)	1 of 12
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
Sentinel Cohort: RSV 120 mcg Age 50-85 Years	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Sentinel Cohort: RSV 240 mcg Age 50-85 Years	1 of 12 (8.3%)	5 of 12 (41.7%)	0 of 12
Sentinel Cohort: Placebo Age 50-85 Years	0 of 12 (0%)	4 of 12 (33.3%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38606958Walsh EE, Falsey AR, Zareba AM, Jiang Q, Gurtman A, Radley D, Gomme E, Cooper D, Jansen KU, Gruber WC, Swanson KA, Schmoele-Thoma B. Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.
Derived from this study: PubMed 34932102Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.
Derived from this study: PubMed 34931667Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Respiratory Tract Infections

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Formulation A and Formulation B in people with Respiratory Tract Infections, run by Pfizer at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination (time frame: Within 14 days after vaccination). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529773, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.