Immunogenicity and Safety of the Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,106
- 试验地点
- 7
- 主要终点
- Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years
研究概览
简要总结
The primary objectives of the study were:
- To demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates of the SP Shz QIV compared with the SP Shz TIV containing the Victoria lineage strain (TIV1) and the SP Shz TIV containing the Yamagata lineage strain (TIV2) for each strain
- To describe the safety profile of each dosage of SP Shz QIV, TIV1 or TIV2
The secondary objectives of the study were:
- Group 1 (subjects 6-35 months): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after the last dose; demonstrate the superiority of the immune response of the 0.5 mL dose of SP Shz QIV compared to 0.25 mL dose of SP Shz QIV group after the last dose; describe the immune response after administration of the last dose of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2.
- Groups 2 through 5 (subjects ≥ 3 years): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after a single dose; describe the immune response after each and every dose for all subjects ≥ 3 years of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2
- Group 2 (subjects 3 to 8 years), previously unvaccinated ,receiving SP Shz QIV: To describe the immune response after administration of each dose of SP Shz QIV, first dose and second dose of SP Shz QIV respectively
- Group 5 (subjects ≥ 65 years only): To assess the compliance, in terms of immunogenicity, of SP Shz QIV with the requirements of the CHMP NfG CPMP/BWP/214/96 in subjects aged 65 years or older.
- To describe the safety profile of SP Shz QIV 0.5 mL after each dose.
详细描述
Study duration per participants approximately is 180 days
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Open-label (single arm for early safety review) in step 1. Modified double-blind in step 2 with an unblinded administrator used at each trial site. The administrator will not be involved in any of the blinded study assessments (e.g., safety).
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: 6 to 35 months, previously unvaccinated, step 1
Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 1: 6 to 35 months, step 2
Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 1: 6 to 35 months, step 2
Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Trivalent Influenza Vaccine 1 SP Shz TIV1 (Biological)
Group 1: 6 to 35 months, step 2
Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Trivalent Influenza Vaccine 2 SP Shz TIV2 (Biological)
Group 2: 3 to 8 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 2: 3 to 8 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Trivalent Influenza Vaccine 1 SP Shz TIV1 (Biological)
Group 2: 3 to 8 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
干预措施: Trivalent Influenza Vaccine 2 SP Shz TIV2 (Biological)
Group 3: 9 to 17 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 3: 9 to 17 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 1 SP Shz TIV1 (Biological)
Group 3: 9 to 17 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 2 SP Shz TIV2 (Biological)
Group 4: 18 to 60 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 4: 18 to 60 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 1 SP Shz TIV1 (Biological)
Group 4: 18 to 60 years, step 2
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 2 SP Shz TIV2 (Biological)
Group 5: >=61 years
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 5: >=61 years
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 1 SP Shz TIV1 (Biological)
Group 5: >=61 years
Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
干预措施: Trivalent Influenza Vaccine 2 SP Shz TIV2 (Biological)
结局指标
主要结局
Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years
时间窗: Day 28
Influenza antibodies will be assessed using the HAI method.
Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months
时间窗: 28 days post-final vaccination
Geometric mean titers will be assessed by a hemagglutination (HAI) method
Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months
时间窗: 28 days post-final vaccination
Influenza antibodies will be assessed using the HAI method.
Number of Participants with Immediate Adverse Events
时间窗: Within 30 minutes after vaccination
Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Number of Participants With Solicited Injection Site or Systemic Reactions
时间窗: Within 7 days after vaccination
Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged \<= 23 months and fever, headache, malaise, myalgia and shivering for participants aged \> 2 years.
Number of Participants with Unsolicited Adverse Events
时间窗: Within 28 days after vaccination
Adverse events other than solicited reactions
Number of Participants with Serious Adverse Events
时间窗: From Day 0 to Day 56 for participants in Group A and from Day 0 to 6 months after last vaccination for participants in Group 1 through Group 5.
Serious adverse events (including adverse event of special interest) are assessed throughout the study.
Geometric Mean Titers of Antibodies for Subjects ≥ 3 years
时间窗: Day 28
Geometric mean titers will be assessed by a HAI method
次要结局
- Geometric Mean Titers of Antibodies(Day 0 and 28 days post-final vaccination)
- Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil])(Day 0 and 28 days post-final vaccination)
- Geometric Mean Individual Titer Ratio(Day 0 and 28 days post-final vaccination)
- Percentage of Participants with Seroprotection to Antigens After Vaccination(Day 0 and 28 days post-final vaccination)
- Percentage of Participants with Seroconversion to Antigens After Vaccination(Day 0 and 28 days post-final vaccination)
- Percentage of Participants with Seroconversion to Antigens After Vaccination for Participants Aged 65 years or Older(Day 0 and 28 days post-final vaccination)
- Geometric Mean Individual Titer Ratio for Participants Aged 65 years or Older(Day 0 and 28 days post-final vaccination)