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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
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.
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, China
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
Time frame: On day 7 after each dose
Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.
Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.
Time frame: Time Frame: within 30 days after the second dose
Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.
Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.
Time frame: within 6 months after the second dose
HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.
HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.
Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
GMI of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
GMI of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
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