Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
NCT ID: NCT05096208
Last Updated: 2023-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1028 participants
INTERVENTIONAL
2021-10-21
2022-04-04
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
DOUBLE
Study Groups
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RSVpreF vaccine Group 1
RSVpreF
RSVpreF (Group 1)
RSV vaccine (RSVpreF)
RSVpreF vaccine Group 2
RSVpreF
RSVpreF (Group 2)
RSV vaccine (RSVpreF)
RSVpreF vaccine Group 3
RSVpreF
RSVpreF (Group 3)
RSV vaccine (RSVpreF)
Placebo dose
Placebo
Placebo
Placebo
Interventions
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RSVpreF (Group 1)
RSV vaccine (RSVpreF)
RSVpreF (Group 2)
RSV vaccine (RSVpreF)
RSVpreF (Group 3)
RSV vaccine (RSVpreF)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after study vaccination.
3. Healthy participants as determined by medical history, physical examination (if required), and the clinical judgment of the investigator to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable in the clinical judgment of the investigator may be included.
4. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
Exclusion Criteria
2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
3. Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 3 months before receipt of study intervention.
4. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
5. Known infection with HIV, HCV, or HBV.
6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
7. Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment or planned receipt throughout the study.
8. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
9. Receipt of monoclonal antibodies from 60 days before study intervention administration or planned receipt throughout the study.
10. Receipt of systemic treatment with known immunosuppressant medications within 60 days before study intervention administration or the use of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to study enrollment. Prednisone use of \<20 mg/day for \<14 days is permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, ears) corticosteroids are permitted.
11. Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
12. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
13. Participation in other studies involving investigational drug(s) or investigational vaccines within 28 days prior to consent and/or during study participation.
14. Pregnant females; breastfeeding females; and women of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study.
15. Men who are unwilling to comply with contraception methods as outlined in the protocol for the duration of the study.
16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
18 Years
49 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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Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Clinical Site Partners, Inc
Winter Park, Florida, United States
Clinical Site Partners
Winter Park, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Aventiv Research Inc
Columbus, Ohio, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Benchmark Research
Austin, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
DM Clinical Research
Tomball, 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
Countries
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References
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Baker J, Aliabadi N, Munjal I, Jiang Q, Feng Y, Brock LG, Cooper D, Anderson AS, Swanson KA, Gruber WC, Gurtman A. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.
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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C3671014
Identifier Type: -
Identifier Source: org_study_id
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