Health TrialsbyHealthPanel

A Study to Learn About mRNA Vaccines Against Influenza in Adults

ConditionHealthy Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Vaccine Candidate #1

    Biological/Vaccine

    Investigational influenza Vaccine

  • Vaccine Candidate #2

    Biological/Vaccine

    Investigational influenza Vaccine

  • Vaccine Candidate #3

    Biological/Vaccine

    Investigational Influenza Vaccine

  • Vaccine Candidate #4

    Biological/Vaccine

    Investigational Influenza Vaccine

  • Vaccine Candidate #5

    Biological/Vaccine

    Investigational Influenza Vaccine

  • Vaccine Candidate #6

    Biological/Vaccine

    Investigational Influenza Vaccine

  • TIV1 or TIV2

    Biological/Vaccine

    Licensed influenza vaccine

Treatment groups

770 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Group D: DExperimental treatment 1 intervention
Group E: EExperimental treatment 1 intervention
Group F: FExperimental treatment 1 intervention
Group G: GActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants reporting prespecified local reactions following vaccination

Time frame
Within 7 days after vaccination
2

Percentage of participants reporting prespecified systemic events following vaccination.

Time frame
Within 7 days after vaccination
3

Percentage of participants reporting adverse events (AEs) following vaccination.

Time frame
Within 1 month after vaccination
4

Percentage of participants reporting serious adverse events (SAEs) following vaccination.

Time frame
Within 6 months after vaccination

Secondary outcomes

1

Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine.

Time frame
Before vaccination and at 4 weeks after vaccination
2

Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine

Time frame
Before vaccination to 4 weeks after vaccination
3

Percentage of participants with satisfactory antibody response to the vaccine.

Time frame
Before vaccination to 4 weeks after vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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