A Phase IV, Randomized, Double-blind, Positive-controlled , Multicenter Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion) , Inactivated (Anflu®) in Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
研究概览
简要总结
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.
详细描述
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in Chinese 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.The trial is a randomized, double-blind, positive controlled study to evaluate the immunogenicity and safety of Influenza Vaccine (Split Virion) ,Inactivated (Anflu®) manufactured by Sinovac. The active control vaccine is VAXIGRIP® manufactured by Sanofi.
For immunogenicity assessment, blood samples will be collected from participants prior to vaccination, 28 days post-vaccination, and at the end of pregnancy (at delivery) to evaluate antibody levels in pregnant women following influenza vaccination. Additionally, the cord blood samples will be collected at delivery to assess transplacental antibody transfer to the fetus. Antibodies will be tested using the hemagglutination-inhibition (HI) assay.
For safety assessment, any immediate adverse events within 30 minutes after vaccine administration, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected from the time of informed consent signature until 3 months after delivery (or until 3 months after the event if pregnancy termination occurs). Pregnancy and neonatal outcomes will be collected by medical record review .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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 singleton pregnancy;
- •Have normal non-invasive prenatal DNA test and systematic ultrasound results during the current pregnancy; normal amniocentesis results are required if the test has been performed.
排除标准
- •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.
- •Have a history of Guillain-Barré syndrome within 6 weeks after previous influenza vaccination.
- •Have allergic reactions or other severe adverse reactions to any influenza vaccine or its components.
- •Have severe autoimmune diseases or immunodeficiency diseases (including but not limited to active systemic lupus erythematosus, rheumatoid arthritis, asplenia, functional asplenia, and HIV infection) and are judged unsuitable for vaccination by the investigator.
- •Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders or platelet abnormalities).
- •Have severe chronic diseases (including but not limited to cardiovascular diseases, partial liver diseases, renal diseases or malignant tumors) that may interfere with the study as judged by the investigator.
- •Have a current or previous history of severe neurological diseases (epilepsy, convulsions) or psychiatric disorders, or have a family history of psychiatric disorders.
- •Received corticosteroids (adult prednisone ≥20 mg/day or equivalent) or other immunosuppressants for ≥14 days, or cytotoxic therapy within 6 months prior to vaccination, or plan to receive such therapy during the study period.
- •Received immunoglobulins or other blood products within 3 months prior to vaccination, or plan to receive such products during the study period.
- •Received any vaccine within 28 days prior to study vaccination, or plan to receive any vaccine within 28 days after study vaccination.
- •Have enrolled in other clinical trials of investigational drugs or vaccines during the follow-up period, or plan to receive investigational drugs or vaccines during the study period.
- •Have acute diseases or acute exacerbation of chronic diseases within 7 days before vaccination.
- •Have fever on the scheduled vaccination day with an axillary temperature ≥37.3 °C before vaccination.
- •Have clinically significant abnormal laboratory findings as judged by the investigator, or meet any of the following laboratory criteria: a) White blood cell count >15.0×10^9/L; b) Neutrophil percentage >85%; c) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (2×ULN); d) Total bilirubin >2 times the upper limit of normal (2×ULN).
- •Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
研究组 & 干预措施
Test Group
100 participants will receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) Inactivated (Anflu®) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Anflu® (Biological)
Control Group
50 participants will receive one dose of vaccine (0.5 mL) of VAXIGRIP® manufactured by Sanofi. Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose
干预措施: Vaxigrip® (Biological)
结局指标
主要结局
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
时间窗: 28 days after vaccination
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
时间窗: 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.
次要结局
- The seroprotection rates (SPRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B(28 days after vaccination)
- The geometric mean titers (GMTs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B(28 days after vaccination)
- The geometric mean fold rises (GMFRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B(28 days after vaccination)
- The SCRs of HI antibodies at delivery, as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery , estimated to be 6-18 weeks after randomization.)
- The SPRs of HI antibodies at delivery ,as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery , estimated to be 6-18 weeks after randomization.)
- The GMTs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery , estimated to be 6-18 weeks after randomization.)
- The GMFRs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery , estimated to be 6-18 weeks after randomization.)
- The SPRs of HI antibodies in cord blood at delivery ,as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery, estimated to be 6-18 weeks after randomization)
- The GMTs of HI antibodies in cord blood at delivery, as measured by HAI assay for vaccine-matched influenza A and B(At the date of delivery, estimated to be 6-18 weeks after randomization)
- Incidence of serious adverse events from vaccination through 3 months after delivery.(From vaccination to 3 months after delivery.)
- Pregnancy outcomes(At the date of delivery, estimated to be 6-18 weeks after randomization)
- Neonatal birth outcomes(3 months after delivery)