Influenza vaccine based on mRNA in adults 18-64

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial tests an investigational mRNA-based seasonal flu vaccine in adults aged 18 to 64. Participants receive a single intramuscular injection and are followed for about six months to monitor immune responses and safety. The study will compare these immune responses with those from adults 65 and older in a separate study. The primary goals are to assess immunogenicity and safety signals, including any adverse medical problems after vaccination. The sponsor is GlaxoSmithKline, with sites in Glendale, Tucson, and San Diego.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
* A male or female participant between and including 18 to 64 years of age at the time of study intervention administration
* Participants of childbearing potential may be enrolled, if the participant:

  * has practiced adequate contraception for at least 30 days prior to study intervention administration, and
  * has a negative urine pregnancy test within 24 hours prior to study intervention administration, and
  * has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.

Exclusion Criteria:

* History of test confirmed influenza infection within 180 days prior to study intervention administration.
* Confirmed or suspected immunosuppressive or immunodeficient condition, except for stable human immunodeficiency virus infection meeting protocol-defined stability criteria.
* History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
* History of hypersensitivity or allergic reaction to any previous influenza vaccine.
* History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
* History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
* Acute or unstable chronic conditions as determined by medical history and clinical examination.
* Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration prior to Visit 2 during the study.
* Planned administration/administration of prohibited vaccines within protocol-defined time windows before or after study intervention administration.
* Use of any investigational or non-registered product (other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or their planned use during the study period.
* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
* Pregnant or lactating female participant.

Where it's running

• GSK Investigational Site
  Glendale, Arizona, United States Recruiting
• GSK Investigational Site
  Tucson, Arizona, United States Recruiting
• GSK Investigational Site
  San Diego, California, United States Recruiting
• GSK Investigational Site
  Miami, Florida, United States Recruiting
• GSK Investigational Site
  Miami Lakes, Florida, United States Recruiting
• GSK Investigational Site
  Meridian, Idaho, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.