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).

Pfizer

Status and phase: Completed; Phase 2

Conditions: Healthy Participants

Treatments: Biological: Combination [RSVpreF+BNTb162b2]; Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: RSVpreF; Biological: QIV; Biological: Normal Saline Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05886777

C5481001

Details and patient eligibility

About

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.

Enrollment: 1,142 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,142 participants in 7 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Biological: QIV

Biological: Combination [RSVpreF+BNTb162b2]

Group 2

Experimental group

Description:

Combination \[RSVpreF+BNT162b2\] + placebo

Treatment:

Biological: Normal Saline Placebo

Biological: Combination [RSVpreF+BNTb162b2]

Group 3

Active Comparator group

Description:

BNT162b2 + placebo

Treatment:

Biological: Normal Saline Placebo

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

Group 4

Active Comparator group

Description:

RSVpreF + placebo

Treatment:

Biological: Normal Saline Placebo

Biological: RSVpreF

Group 5

Active Comparator group

Description:

QIV + placebo

Treatment:

Biological: Normal Saline Placebo

Biological: QIV

Group 6

Experimental group

Description:

Coadministration RSVpreF + bivalent BNT162b2 + placebo

Treatment:

Biological: Normal Saline Placebo

Biological: RSVpreF

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

Group 7

Experimental group

Description:

Coadministration RSVpreF + bivalent BNT162b2 + QIV

Treatment:

Biological: QIV

Biological: RSVpreF

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