To Identify the Immunogenicity and Safety of Inavtivated Quadrivalent Influenza Virus Split Vaccine in Children Aged 3-8 Years With Two Doses and One Dose Pre-immunization (QIV)

NCT05389137 Phase 4 UNKNOWN

To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group. All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.

Details

Lead sponsor	Wuhan Institute of Biological Products Co., Ltd
Phase	Phase 4
Status	UNKNOWN
Enrolment	360
Start date	2022-03-02
Completion	2022-10

Conditions

• Influenza

Interventions

• Inavtivated Quadrivalent Influenza Virus Split Vaccine

Primary outcomes

• Seroconversion Rate (SCR) — 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
  Seroconversion Rate (SCR) of HI antibodies of 4 vaccine strain types in all subjects
• Seroprotection Rate (SPR) — 28 days after the first dose of trial vaccine, 30 days after the second dose of trial vaccine.
  Seroprotection Rate (SPR) of HI antibodies of 4 vaccine types in all subjects
• Geometric Mean Titer — 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
  Geometric Mean Titer of HI antibodies of 4 vaccine types in all subjects
• Incidence of adverse reactions — Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
  Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
• Incidence of all adverse events — • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
  • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
• Incidence of all serious adverse events — Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
  Incidence of all serious adverse events from the first dose to 6 months after full vaccination;

Countries

China