Clinical trial NCT05886777: 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).
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Participants
Keywords: SARS-CoV-2
COVID-19
Flu
Influenza
Vaccine
RSV
Respiratory Syncytial Virus
Combination vaccine
mRNA vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 1142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
timeFrame: Day 1 to Day 7 after Vaccination on Day 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Day 1 to Day 7 after Vaccination on Day 1
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 Month after Vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: Within 6 Months after Vaccination
measure: 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
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: 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
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3
timeFrame: 1 Month after Vaccination
Secondary outcomes:
measure: GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3
timeFrame: 1 Month after Vaccination
measure: GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3
timeFrame: 1 Month after Vaccination
Other outcomes:
Locations:
city: Dublin
country: United States
facility: West Coast Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Lake City
country: United States
facility: Wr-Msra.Llc
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba CSP Orlando
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials - Gurnee
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLD dba QPS-MO
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Wilmington
country: United States
facility: Accellacare - Wilmington - 1917 Tradd Court
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Brownsville
country: United States
facility: Headlands Horizons LLC
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Cy Fair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- Cyfair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research, Martin Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: