Menu
Recruiting NCT07431853

A Study to Learn About mRNA Vaccines Against Influenza in Adults

Phase II Interventional Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vaccine Candidate #1, Vaccine Candidate #2, Vaccine Candidate #3, Vaccine Candidate #4.
Who it may be relevant to
Registry conditions: Healthy Adults. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MRNA VACCINES AGAINST INFLUENZA IN ADULTS 18 YEARS OF AGE AND OLDER

Overview

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.

Interventions

  • Biological Vaccine Candidate #1
    Investigational influenza Vaccine
  • Biological Vaccine Candidate #2
    Investigational influenza Vaccine
  • Biological Vaccine Candidate #3
    Investigational Influenza Vaccine
  • Biological Vaccine Candidate #4
    Investigational Influenza Vaccine
  • Biological Vaccine Candidate #5
    Investigational Influenza Vaccine
  • Biological Vaccine Candidate #6
    Investigational Influenza Vaccine
  • Biological TIV1 or TIV2
    Licensed influenza vaccine

Primary outcome measures

  • Percentage of participants reporting prespecified local reactions following vaccination [Time frame: Within 7 days after vaccination]
  • Percentage of participants reporting prespecified systemic events following vaccination. [Time frame: Within 7 days after vaccination]
  • Percentage of participants reporting adverse events (AEs) following vaccination. [Time frame: Within 1 month after vaccination]
  • Percentage of participants reporting serious adverse events (SAEs) following vaccination. [Time frame: Within 6 months after vaccination]
  • Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination. [Time frame: Within 6 months after vaccination]
Secondary outcome measures (3)
  • 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]
  • 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]
  • Percentage of participants with satisfactory antibody response to the vaccine. [Time frame: Before vaccination to 4 weeks after vaccination]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 15 centers
  • AMR Clinical — Mobile
  • Diablo Clinical Research, LLC d/b/a Flourish Research — Walnut Creek
  • Clinical Research Consulting, LLC — Milford
  • George Washington Medical Faculty Associates — Washington D.C.
  • Indago Research & Health Center, Inc — Hialeah
  • Palm Springs Community Health Center — Miami Lakes
  • Clinical Research Atlanta — Stockbridge
  • East-West Medical Research Institute — Honolulu
  • … and 7 more centers

Identifiers

NCT: NCT07431853 · C6481001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗