A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,561
- 试验地点
- 24
- 主要终点
- Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
研究概览
简要总结
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).
The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.
The total study participation time per subject is about 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18 through 49 years of age.
- •Subjects having provided informed consent.
- •Individuals in good health
排除标准
- •Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- •Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
研究组 & 干预措施
TIVc-Lot A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
干预措施: TIVc_LOT A (Biological)
TIVc-Lot B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
干预措施: TIVc_LOT B (Biological)
TIVc-Lot C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
干预措施: TIVc_LOT C (Biological)
TIVf
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
干预措施: TIVf (Biological)
结局指标
主要结局
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
时间窗: Day 22
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
次要结局
- Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf(Day 1 through day 7 (without 30 min))
- Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.(Day 22)
- Number of Subjects With Unsolicited Adverse Events(Day 1 through day 22)