Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

Sponsor
Shanghai Institute Of Biological Products
Study ID
NCT07327398
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Influenza

Eligibility Criteria

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

Interventions

  • Influenza virus split vaccine (0.7mL/vial) — BIOLOGICAL
    Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.
  • Influenza virus split vaccine — BIOLOGICAL
    Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.

Study Details

To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.

Key Dates

First listed
Jan 8, 2026
Start date
Jan 7, 2026
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Influenza virus split vaccine (0.7mL/vial)
    Influenza virus split vaccine (0.7mL/vial)
  • Active Comparator: Influenza virus split vaccine
    Influenza virus split vaccine

Primary Outcome Measure

Seroconversion rate [ Time Frame: 30 days after vaccination ]

Central Contacts

Related Studies