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).

NCT05886777 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C5481001
• Study Type: interventional
• Target: 1,142
• Locations: 1 country
• Sites: 37

Brief Summary

The purpose of the study is to learn 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.

Conditions

Healthy Participants

Keywords

SARS-CoV-2; COVID-19; Flu; Influenza; Vaccine; RSV; Respiratory Syncytial Virus; Combination vaccine; mRNA vaccine

Outcome Measures

Primary Outcomes (16)

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination

  Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.

  Day 1 to Day 7 after Vaccination on Day 1

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination

  Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity.

  Day 1 to Day 7 after Vaccination on Day 1

• Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

  An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure.

  Within 1 Month after Vaccination

• Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.

  Within 6 Months after Vaccination

• Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3

  GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

  1 Month after Vaccination

Secondary Outcomes (12)

• GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4

  1 Month after Vaccination

• GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3

  1 Month after Vaccination

• GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3

  1 Month after Vaccination

• GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

  1 Month after Vaccination

Study Arms (7)

Group 1

EXPERIMENTAL

Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)

Biological: Combination [RSVpreF+BNTb162b2]; Biological: QIV

Group 2

EXPERIMENTAL

Combination \[RSVpreF+BNT162b2\] + placebo

Biological: Combination [RSVpreF+BNTb162b2]; Biological: Normal Saline Placebo

Group 3

ACTIVE COMPARATOR

BNT162b2 + placebo

Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: Normal Saline Placebo

Group 4

ACTIVE COMPARATOR

RSVpreF + placebo

Biological: RSVpreF; Biological: Normal Saline Placebo

Group 5

ACTIVE COMPARATOR

QIV + placebo

Biological: QIV; Biological: Normal Saline Placebo

Group 6

EXPERIMENTAL

Coadministration RSVpreF + bivalent BNT162b2 + placebo

Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: RSVpreF; Biological: Normal Saline Placebo

Group 7

EXPERIMENTAL

Coadministration RSVpreF + bivalent BNT162b2 + QIV

Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: RSVpreF; Biological: QIV

Interventions

Combination [RSVpreF+BNTb162b2] BIOLOGICAL

Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection

Group 1; Group 2

Bivalent BNT162b2 (original/Omi BA.4/BA.5) BIOLOGICAL

Bivalent BNT162b2 given as an intramuscular injection

Group 3; Group 6; Group 7

RSVpreF BIOLOGICAL

RSVpreF given as an intramuscular injection

Group 4; Group 6; Group 7

QIV BIOLOGICAL

Licensed QIV given as an intramuscular injection

Group 1; Group 5; Group 7

Normal Saline Placebo BIOLOGICAL

Normal saline (0.9% sodium chloride solution for injection)

Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female participants ≥65 years of age at Visit 1 (Day 1).
• Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
• 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.
• 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).

You may not qualify if:

• A confirmed diagnosis of COVID 19, RSV infection, or influenza ≤120 days before study intervention administration.
• History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• 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.
• 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.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
• Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
• Receipt of any influenza vaccine ≤120 days before study enrollment.
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

West Coast Research

Dublin, California, 94568, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Wr-Msra.Llc

Lake City, Florida, 32055, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Clinical Site Partners, LLC dba CSP Orlando

Winter Park, Florida, 32789, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

Great Lakes Clinical Trials - Gurnee

Gurnee, Illinois, 60031, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)

Springfield, Missouri, 65802, United States

Location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Bio-Kinetic Clinical Applications, LLD dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Las Vegas Clinical Trials

Las Vegas, Nevada, 89030, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Accellacare - Wilmington - 1917 Tradd Court

Wilmington, North Carolina, 28401, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Headlands Horizons LLC

Brownsville, Texas, 78526, United States

Location

DM Clinical Research - Cy Fair

Houston, Texas, 77065, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

DM Clinical Research - Bellaire

Houston, Texas, 77081, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

DM Clinical Research, Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Virginia Research Center

Midlothian, Virginia, 23114, United States

Location

Related Publications (1)

• 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.

  PMID: 40006705 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 2, 2023
• Study Start: June 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (37)