A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,680
- 试验地点
- 40
- 主要终点
- 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
研究概览
简要总结
Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18 years and older.
- •Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.
排除标准
- •Individuals recently vaccinated against influenza
- •Subjects with contraindications to receive influenza vaccine
- •Please contact the site for additional eligibility criteria
结局指标
主要结局
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
时间窗: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
时间窗: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
次要结局
- 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts(Three weeks post vaccination (Day 22))
- 4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts(Three weeks post vaccination (Day 22))
- 5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts(Three weeks post vaccination (Day 22))
- 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group(Day 1 to 7 post vaccination)
- 7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts(Three weeks post vaccination (Day 22))
- 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain(Three weeks post vaccination (Day 22))
- 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain(Three weeks post vaccination (Day 22))
- 6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts(Three weeks post vaccination (Day 22))
- 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain(Three weeks post vaccination (Day 22))
- 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain(Three weeks post vaccination (Day 22))
- 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group(Day 1 to 181 post vaccination)