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

Sponsor
Shanghai Institute Of Biological Products
Study ID
NCT07302256
Phase
PHASE1
Status
Recruiting
Apply to this trial

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
  • 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
  • Phosphate buffer solution (PBS) — BIOLOGICAL
    PBS, with a specification of 0.5mL/bottle.

Study Details

This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.

Key Dates

First listed
Dec 24, 2025
Start date
Dec 16, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Experimental: Experimental group
    Influenza virus split vaccine, with a specification of 0.7mL/bottle
  • Active Comparator: Control group 1
    Influenza virus split vaccine, with a specification of 0.5mL/bottle
  • Placebo Comparator: Control group 2
    Phosphate buffer solution

Primary Outcome Measure

Unsolicited Adverse Events [ Time Frame: 30 days after vaccination ]

Central Contacts

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