A Study to Learn About mRNA Vaccines Against Influenza in Adults

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Healthy Adults

Treatments: Biological: Vaccine Candidate #2; Biological: Vaccine Candidate #6; Biological: Vaccine Candidate #5; Biological: Vaccine Candidate #3; Biological: Vaccine Candidate #1; Biological: TIV1 or TIV2; Biological: Vaccine Candidate #4

Study type: Interventional

Funder types: Industry

Identifiers

NCT07431853

C6481001

Details and patient eligibility

About

The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus).

This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison.

Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.

Enrollment: 770 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria

• Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1).
• Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1).
• Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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770 participants in 7 patient groups

A

Experimental group

Description:

mRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1.

Treatment:

Biological: Vaccine Candidate #1

B

Experimental group

Description:

mRNA influenza vaccine candidate #2 as a single IM injection on Day 1.

Treatment:

Biological: Vaccine Candidate #2

C

Experimental group

Description:

mRNA influenza vaccine candidate #3 as a single IM injection on Day 1.

Treatment:

Biological: Vaccine Candidate #3

D

Experimental group

Description:

mRNA influenza vaccine candidate #4 as a single IM injection on Day 1.

Treatment:

Biological: Vaccine Candidate #4

E

Experimental group

Description:

mRNA influenza vaccine candidate #5 as a single IM injection on Day 1.

Treatment:

Biological: Vaccine Candidate #5

F

Experimental group

Description:

mRNA influenza vaccine candidate #6 as a single IM injection on Day 1.

Treatment:

Biological: Vaccine Candidate #6

G

Active Comparator group

Description:

Licensed influenza vaccine (TIV1 or TIV2) as a single IM injection.

Treatment:

Biological: TIV1 or TIV2