A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Pediatric Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 662
- 试验地点
- 24
- 主要终点
- The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain
研究概览
简要总结
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy pediatric subjects 6 months to 17 years of age,
- •Individuals' parent(s) or legal guardian(s) willing to provide written informed consent,
- •Individuals in good health,
- •Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
- •Individuals willing to provide informed assent (where applicable).
排除标准
- •Individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures,
- •History of any significant illness,
- •History of any chronic medical condition or progressive disease,
- •Presence of medically significant cancer,
- •Known or suspected impairment/alteration of immune function,
- •Presence of any progressive or severe neurologic disorder,
- •Presence of any bleeding disorders or conditions that prolongs bleeding time,
- •History of allergy to vaccine components,
- •Receipt of any other investigational product within 30 days prior to entry into the study,
- •History of previous H5N1 vaccination,
- •Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
- •Receipt of any other vaccine within 2 weeks prior to entry into the study,
- •Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
- •Pregnant or breast feeding,
- •Females of childbearing potential refusing to use acceptable method of birth control,
- •Body mass index (BMI) ≥ 35 kg/m2,
- •History of drug or alcohol abuse,
- •Any planned surgery during study period,
- •Individuals conducting the study and their immediate family members,
- •Individuals with behavioral or cognitive impairment or psychiatric diseases,
- •Individuals diagnosed with any growth disorders.
研究组 & 干预措施
aH5N1c-High dose
干预措施: Adjuvanted H5N1 pandemic influenza vaccine (Biological)
aH5N1c-Low dose
干预措施: Adjuvanted H5N1 pandemic influenza vaccine (Biological)
结局指标
主要结局
The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
Immunogenicity was measured in terms of the percentages of subjects aged 3 to \<9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
Immunogenicity was measured in terms of the percentages of subjects aged 9 to \<18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to \<36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to \<18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination
时间窗: From day 1 through day 7 after each vaccination.
Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to \<9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain
时间窗: Three weeks after 2nd vaccination (day 43)
Immunogenicity was measured in terms of the percentages of subjects aged 6 to \<36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria. Seroconversion is defined as the percentages of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Number of Subjects (≥6 Years - 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination
时间窗: From day 1 through day 7 after any vaccination.
Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination
时间窗: Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.
次要结局
- Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain(Day 1, day 22, day 43 and day 387.)
- Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.(Day 1, day 22, day 43 and day 387)
- Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.(Day 1, day 22, day 43 and day 387)
- Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain(Day 1, day 22, day 43 and day 387.)
- Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.(Day 1, day 22, day 43 and day 387)
- Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain(Day 1, day 22, day 43 and day 387.)
- The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain(Day 22, day 43 and day 387)
- The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain(Day 22, day 43 and day 387)
- The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain(Day 22, day 43 and day 387)