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).

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886777
• Other study ID #: C5481001
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1084
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Healthy Participants

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
United States	Headlands Horizons LLC	Brownsville	Texas
United States	Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio
United States	West Coast Research	Dublin	California
United States	Great Lakes Clinical Trials - Gurnee	Gurnee	Illinois
United States	Drug Trials America	Hartsdale	New York
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	DM Clinical Research - Bellaire	Houston	Texas
United States	DM Clinical Research - Cy Fair	Houston	Texas
United States	DM Clinical Research- Cyfair	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Wr-Msra.Llc	Lake City	Florida
United States	Orange County Research Center	Lake Forest	California
United States	Las Vegas Clinical Trials	Las Vegas	Nevada
United States	Optimal Research	Melbourne	Florida
United States	SMS Clinical Research	Mesquite	Texas
United States	Suncoast Research Group	Miami	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	Clinical Research Consulting	Milford	Connecticut
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Las Vegas Clinical Trials	North Las Vegas	Nevada
United States	Optimal Research	Peoria	Illinois
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	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Research Foundation	San Diego	California
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	DM Clinical Research	Tomball	Texas
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Accellacare - Wilmington	Wilmington	North Carolina
United States	Accellacare - Wilmington - 1917 Tradd Court	Wilmington	North Carolina
United States	Clinical Site Partners, LLC dba CSP Orlando	Winter Park	Florida
United States	Clinical Site Partners, LLC dba Flourish Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling	For up to 7 days following vaccination (Day 7)
Primary	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)
Primary	Percentage of participants reporting adverse events	As elicited by investigational site staff	Within 1 month following vaccination (Day 28)
Primary	Percentage of participants reporting serious adverse events	As elicited by investigational site staff	Within 6 months following vaccination (Day 175)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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