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).

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATE(S) AGAINST INFECTIOUS RESPIRATORY ILLNESSES, INCLUDING COVID-19 AND RSV, IN HEALTHY INDIVIDUALS

The purpose of the study is tolearn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Biological: Combination [RSVpreF+BNTb162b2]; Biological: QIV; Biological: Normal Saline Placebo; Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: RSVpreF

• Study Type: Interventional
• Enrollment (Actual): 1084
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • California
    • Dublin, California, United States, 94568
      • West Coast Research
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • San Diego, California, United States, 92123
      • California Research Foundation
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Lake City, Florida, United States, 32055
      • Wr-Msra.Llc
    • Melbourne, Florida, United States, 32934
      • Optimal Research
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, LLC dba CSP Orlando
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, LLC dba Flourish Research
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Great Lakes Clinical Trials - Gurnee
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLD dba QPS-MO
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington - 1917 Tradd Court
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Centricity Research Columbus Ohio Multispecialty
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Brownsville, Texas, United States, 78526
      • Headlands Horizons LLC
    • Houston, Texas, United States, 77065
      • DM Clinical Research - Cy Fair
    • Houston, Texas, United States, 77081
      • DM Clinical Research - Bellaire
    • Houston, Texas, United States, 77065
      • DM Clinical Research- Cyfair
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Virginia Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Substudy A Inclusion Criteria:

1. Male or female participants ≥65 years of age at Visit 1 (Day 1).
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).

Substudy A Exclusion Criteria:

1. A confirmed diagnosis of COVID 19, RSV infection, or influenza ≤120 days before study intervention administration.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)	Biological: Combination [RSVpreF+BNTb162b2]; Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection; Biological: QIV; Licensed QIV given as an intramuscular injection
Experimental: Group 2; Combination [RSVpreF+BNT162b2] + placebo	Biological: Combination [RSVpreF+BNTb162b2]; Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection; Biological: Normal Saline Placebo; Normal saline (0.9% sodium chloride solution for injection)
Active Comparator: Group 3; BNT162b2 + placebo	Biological: Normal Saline Placebo; Normal saline (0.9% sodium chloride solution for injection); Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Bivalent BNT162b2 given as an intramuscular injection
Active Comparator: Group 4; RSVpreF + placebo	Biological: Normal Saline Placebo; Normal saline (0.9% sodium chloride solution for injection); Biological: RSVpreF; RSVpreF given as an intramuscular injection
Active Comparator: Group 5; QIV + placebo	Biological: QIV; Licensed QIV given as an intramuscular injection; Biological: Normal Saline Placebo; Normal saline (0.9% sodium chloride solution for injection)
Experimental: Group 6; Coadministration RSVpreF + bivalent BNT162b2 + placebo	Biological: Normal Saline Placebo; Normal saline (0.9% sodium chloride solution for injection); Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Bivalent BNT162b2 given as an intramuscular injection; Biological: RSVpreF; RSVpreF given as an intramuscular injection
Experimental: Group 7; Coadministration RSVpreF + bivalent BNT162b2 + QIV	Biological: QIV; Licensed QIV given as an intramuscular injection; Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Bivalent BNT162b2 given as an intramuscular injection; Biological: RSVpreF; RSVpreF given as an intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling	For up to 7 days following vaccination (Day 7)
Percentage of participants reporting systemic events	Fever, fatigue, headache, vomiting, diarrhea, chills, new or worsened muscle pain, and new or worsened joint pain	For up to 7 days following vaccination (Day 7)
Percentage of participants reporting adverse events	As elicited by investigational site staff	Within 1 month following vaccination (Day 28)
Percentage of participants reporting serious adverse events	As elicited by investigational site staff	Within 6 months following vaccination (Day 175)
Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 1 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratios (GMRs) of hemagglutination inhibition (HAI) titers.	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 2 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)	As measured at central laboratory.	1 month after vaccination (Day 28)
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers NTs	As measured at central laboratory.	1 month after vaccination (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group 7 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)
Group 7 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers.	As measured at central laboratory	1 month after vaccination (Day 28)
Group 6 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)	As measured at central laboratory	1 month after vaccination (Day 28)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Influenza; Vaccine; COVID-19; RSV; Flu; mRNA vaccine; Respiratory Syncytial Virus; Combination vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: C5481001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No