A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women.
A total of 150 healthy pregnant women aged 18\~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) , Inactivated (Anflu®) or Sanofi VAXIGRIP®, respectively.
Healthy pregnant women aged 18 to 45 years (inclusive) with stable health status, at 22 to 34 weeks (+6 days) of gestation. Gestational age is determined based on early ultrasound examination, or based on the last menstrual period if early ultrasound is unavailable.
Participants are able to understand and sign the informed consent form voluntarily;
Participants are willing and able to adhere to visit schedules and maintain accessible contact throughout the study period;
Participants should provide verifiable identification;
Have a history of two or more preterm deliveries (delivery before 37 weeks of gestation), previous infants with low birth weight (birth weight <2500 g), or a history of neonatal asphyxia or neonatal neurological damage;
Have a history of multiple unexplained spontaneous abortions;
Have received any influenza vaccine or the influenza vaccine for the current influenza season within 6 months prior to enrollment, or plan to receive influenza vaccination during the study period.
Have suffered from seasonal influenza within 6 months prior to enrollment.
Parallel
Anflu®
Biological/VaccineParticipants will receive one dose of Sinovac Anflu® .
Vaxigrip®
Biological/VaccineParticipants will receive one dose of Sanofi Vaxigrip®.
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer \<1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer.
Incidence of adverse reactions within 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination. Adverse reactions include solicited and unsolicited adverse reactions. Solicited local (injection site) symptoms: pain, swelling, erythema, induration, pruritus; Solicited systemic (non-injection site) symptoms: fever (axillary temperature), fatigue, myalgia, headache, hypersensitivity reaction.
The seroprotection rates (SPRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40.
The geometric mean titers (GMTs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs.
The geometric mean fold rises (GMFRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Geometric mean of antibody fold-rise with two-sided 95% CI will be calculated , along with the geometric mean ratio and its corresponding two-sided 95% CI.
The SCRs of HI antibodies at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer \<1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer.
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