A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).
NCT ID: NCT05886777
Last Updated: 2024-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1142 participants
INTERVENTIONAL
2023-06-05
2024-01-01
Brief Summary
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This study is seeking participants who:
* are 65 years of age or older.
* are healthy or have well-controlled chronic conditions.
* in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1).
* have not had a flu shot in the last 120 days.
* agree to be present for all study visits, procedures, and blood draws.
Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group 1
Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)
Combination [RSVpreF+BNTb162b2]
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
QIV
Licensed QIV given as an intramuscular injection
Group 2
Combination \[RSVpreF+BNT162b2\] + placebo
Combination [RSVpreF+BNTb162b2]
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Group 3
BNT162b2 + placebo
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
Bivalent BNT162b2 given as an intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Group 4
RSVpreF + placebo
RSVpreF
RSVpreF given as an intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Group 5
QIV + placebo
QIV
Licensed QIV given as an intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Group 6
Coadministration RSVpreF + bivalent BNT162b2 + placebo
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
Bivalent BNT162b2 given as an intramuscular injection
RSVpreF
RSVpreF given as an intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Group 7
Coadministration RSVpreF + bivalent BNT162b2 + QIV
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
Bivalent BNT162b2 given as an intramuscular injection
RSVpreF
RSVpreF given as an intramuscular injection
QIV
Licensed QIV given as an intramuscular injection
Interventions
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Combination [RSVpreF+BNTb162b2]
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
Bivalent BNT162b2 given as an intramuscular injection
RSVpreF
RSVpreF given as an intramuscular injection
QIV
Licensed QIV given as an intramuscular injection
Normal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Eligibility Criteria
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Inclusion Criteria
2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
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 this protocol.
5. Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1).
Exclusion Criteria
2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
5. Allergy to egg proteins (egg or egg products) or chicken proteins.
6. Any 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. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
8. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
9. Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
10. Receipt of any influenza vaccine ≤120 days before study enrollment.
11. Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
65 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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West Coast Research
Dublin, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Orange County Research Center
Lake Forest, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Research Foundation
San Diego, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Wr-Msra.Llc
Lake City, Florida, United States
Optimal Research
Melbourne, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Clinical Site Partners, LLC dba CSP Orlando
Winter Park, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, United States
Optimal Research
Peoria, Illinois, United States
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
Springfield, Missouri, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Drug Trials America
Hartsdale, New York, United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
Headlands Horizons LLC
Brownsville, Texas, United States
DM Clinical Research - Cy Fair
Houston, Texas, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
DM Clinical Research, Martin Diagnostic Clinic
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
Virginia Research Center
Midlothian, Virginia, United States
Countries
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References
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Neutel JM, Erdem R, Jiang Q, Cannon K, Stacey H, Newton R, Gomme E, Li W, Mensa FJ, Tureci O, Sahin U, Swanson KA, Munjal I, Cooper D, Koury K, Anderson AS, Gurtman A, Kitchin N; C5481001 Study Group. Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults >/= 65 Years of Age. Vaccines (Basel). 2025 Feb 5;13(2):158. doi: 10.3390/vaccines13020158.
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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C5481001
Identifier Type: -
Identifier Source: org_study_id