COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 3
- 主要终点
- Single dose of bOPV (from Sanofi Pasteur bulk) induces similar levels of seroconversion against poliovirus types 1 or 3, respectively than does one dose of bOPV (from PT BioFarma bulk)
研究概览
简要总结
COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIAL.Primary objective being -The principal purpose of the study is to demonstrate the non inferiority of one doses of bOPV (from Sanofi Pasteur bulk) compared with bOPV (from PT BioFarma bulk).Also adverse events following vaccine administration will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.50 Month(s) 至 2.50 Month(s)（—）
- 性别
- All
入选标准
- •Infants between 6 weeks to 10 weeks of age born healthy (2.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance (<30 km), and not planning to travel away during the entire study period (birth-1 months).
排除标准
- •Newborns requiring hospitalization, birth weight below 2.50 kg, residence >30 km from study site, or families expecting to be absent during the 30-day study period.
- •A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study.
结局指标
主要结局
Single dose of bOPV (from Sanofi Pasteur bulk) induces similar levels of seroconversion against poliovirus types 1 or 3, respectively than does one dose of bOPV (from PT BioFarma bulk)
时间窗: Sera collected at enrollment and 30 day visit, will be examined for the presence (detectable) or absence of neutralizing antibodies to type 1 and 3 poliovirus serotypes
次要结局
- monitor adverse events following vaccine administration(follow up of 30 days post vaccination)