Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.

Sponsor
Sanofi
Study ID
NCT07779408
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers
  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Flu H5 egg pandemic low dose vaccine, with adjuvant — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
  • Flu H5 Egg Pandemic medium dose vaccine, with adjuvant — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
  • Flu H5 Egg Pandemic high dose vaccine, with adjuvant — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
  • Flu H5 Egg Pandemic high dose vaccine, without adjuvant — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Study Details

The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness. The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose). Study duration per participant: approximately 14 months (including screening visit).

Key Dates

First listed
Aug 21, 2026
Start date
Aug 10, 2026
Status verified
Aug 2026
Primary completion
Feb 22, 2028
Completion
Feb 22, 2028

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1: Flu H5 egg pandemic low dose vaccine, with adjuvant
    Participants receive 2 intramuscular injections of flu H5 egg pandemic low dose vaccine, with adjuvant
  • Experimental: Group 2: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
    Participants receive 2 intramuscular injections of flu H5 egg pandemic medium dose vaccine, with adjuvant
  • Experimental: Group 3: Flu H5 Egg Pandemic high dose vaccine, with adjuvant
    Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, with adjuvant
  • Experimental: Group 4: Flu H5 Egg Pandemic high dose vaccine, without adjuvant
    Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, without adjuvant

Primary Outcome Measure

Number of participants with immediate Adverse Events (AEs) [ Time Frame: Within 30 minutes after each vaccination ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

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