A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      In this single-center, randomized, blinded, positive-controlled design, the investigators
      will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza
      vaccine in children aged 6 to 35 months.

      About 120 healthy participants are planned to be enrolled, of who 60 participants were
      enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In
      the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent
      inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and
      B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1,
      A/H3N2 and B/Victoria, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. In the
      high-dose group, participants were randomly (2:1:1) assigned to receive IIV4 at 0.5 mL, and
      IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Victoria, and IV3 at 0.25 mL including
      A/H1N1, A/H3N2, and B/Yamagata. Subjects receive 2 doses of influenza vaccine 4 weeks apart.

      The occurrence of adverse reactions within 30 minutes, the occurrence of adverse reactions
      within 28 days, and serious adverse events within 6 months after vaccination will be observed
      in all participants. For participants aged 24-35 months in each dose group, laboratory safety
      tests were measured before enrollment and on day 4 post each dose to assess any toxic
      effects. In addition, all subjects will be required to collect blood for HI antibody testing
      before the first dose of vaccination and 30 days after the second dose of vaccination.
    


Intervention name(s): quadrivalent influenza split vaccine; quadrivalent influenza split vaccine; Influenza virus split vaccine; Influenza virus split vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection; This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection; This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection; This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; quadrivalent influenza split vaccine; reactogenicity; immunogenicity