A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
NCT ID: NCT03529773
Last Updated: 2022-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1235 participants
INTERVENTIONAL
2018-04-18
2020-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Sentinel Arm 1
Low dose formulation A
Formulation A
RSV vaccine
Sentinel Arm 2
Mid dose formulation A
Formulation A
RSV vaccine
Sentinel Arm 3
High dose formulation A
Formulation A
RSV vaccine
Sentinel Arm 4
Low dose formulation B
Formulation B
RSV vaccine
Sentinel Arm 5
Mid dose formulation B
Formulation B
RSV vaccine
Sentinel Arm 6
High dose formulation B
Formulation B
RSV vaccine
Sentinel Arm 7
Placebo
Placebo
Placebo
Expanded Arm 8
Low dose formulation A and SIIV
Formulation A
RSV vaccine
Expanded Arm 9
Mid dose formulation A and SIIV
Formulation A
RSV vaccine
Expanded Arm 10
High dose formulation A and SIIV
Formulation A
RSV vaccine
Expanded Arm 11
Low dose formulation B and SIIV
Formulation B
RSV vaccine
Expanded Arm 12
Mid dose formulation B and SIIV
Formulation B
RSV vaccine
Expanded Arm 13
High dose formulation B and SIIV
Formulation B
RSV vaccine
Expanded Arm 14
Low dose formulation A and placebo
Formulation A
RSV vaccine
Expanded Arm 15
Mid dose formulation A and placebo
Formulation A
RSV vaccine
Expanded Arm 16
High dose formulation A and placebo
Formulation A
RSV vaccine
Expanded Arm 17
Low dose formulation B and placebo
Formulation B
RSV vaccine
Expanded Arm 18
Mid dose formulation B and placebo
Formulation B
RSV vaccine
Expanded Arm 19
High dose formulation B and placebo
Formulation B
RSV vaccine
Expanded Arm 20
placebo and placebo
Placebo
Placebo
Interventions
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Formulation A
RSV vaccine
Formulation B
RSV vaccine
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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 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.
5. Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
6. 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).
Exclusion Criteria
2. 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.
3. 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.
4. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
5. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
7. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
8. Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
9. 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.
10. 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).
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
12. 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.
13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
14. Women who are pregnant or breastfeeding.
15. Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
16. Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.
18 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Anaheim Clinical Trials
Anaheim, California, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California, United States
Paradigm Clinical Research Center
Redding, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Meridian Clinical Research Dakota Dunes
Sioux City, Iowa, United States
Augusta Family Practice
Augusta, Kansas, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Axtell Clinic, P.A.
Newton, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Regional Health/Rochester General Hospital
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Benchmark Research
Austin, Texas, United States
Texas Health Care, PLLC
Fort Worth, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
HealthFirst Medical Group
Fort Worth, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City, Utah, United States
J.Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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RSV FIH
Identifier Type: OTHER
Identifier Source: secondary_id
C3671001
Identifier Type: -
Identifier Source: org_study_id
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