A multicentric, single blind, parallel, randomized, phase-III study to evaluate the immunogenicity & safety of BEs combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy Indian subjects at 6-10-14 weeks EPI schedule in comparison with marketed Shan5 vaccine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Primary Endpoint - Proportion of subjects achieving seroprotection rates in antibody titres against all the five components in each treatment group at Day 84.
研究概览
简要总结
A multicentric, single blind, parallel, randomized (2:1), phase-III study to evaluate the immunogenicity & safety of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy infants at three centres in India. The primary outcome measure is To evaluate BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Shan5 based on proportion of subjects achieving seroprotection levels of antibody titres against diphtheria, tetanus, pertussis, hepatitis-B and HI type B at Day 84. The secondary outcomes will be to evaluate a) immunogenicity of both the vaccines at Day 84 in terms of Geometric Mean Titres (GMTs) b) fold rise in antibody titres above the seroprotection cut off value against each of the five components c) safety and reactogenicity of BE’s liquid pentavalent DTwPrHepB-HIB vaccine in comparison with Shan5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Intended subjects will be healthy infants between 6 to8 weeks of age that is 42 to 56 days of age,both days inclusive of either gender at the time of 1st vaccination.
- •2.Written informed consent obtained from the subject’s parents or legal representative or guardian.
- •3.Healthy infants with weight greater than or equal to 3300 gms at the time of screening.
- •4.Good clinical condition established by medical history and physical examination with no acute disease, infection or high temperature that is greater then 38.5 degrees C axillary temperature.
- •5.Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
- •6.Subjects or their mothers not participating in any other trials.
- •7.Infants without contraindications or precautionary circumstances for participating in the trial 8.Ability of the subject’s parent or legal representative or guardian to understand and comply with the requirements of the protocol.
排除标准
- •Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine; Current illness (especially fever) or any acute or congenital illness or disability; Known or suspected allergy to any of the vaccine components;Â Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS); Known family history of SIDS (Sudden Infant Death Syndrome);Â Inability or unwillingness to abide by the requirements of the protocol;Â Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
Primary Endpoint - Proportion of subjects achieving seroprotection rates in antibody titres against all the five components in each treatment group at Day 84.
时间窗: By the end of 84th day from 1st vaccination.
次要结局
- Antibody titres rise against each of the five antigen component(GMTs estimated both at baseline 0 day and again on 84th day.)
- Proportion of subjects achieving 4-fold rise of antibody titres above the cutoff levels.(Estimated at 84th day after 1st vaccination)
- Occurance of both solicited and unsolicited local and systemic adverse events(1. First 60 minutes post vaccination.2. until 7 days post vaccination through diary.3. upto 28th day post vaccination.4. SAEs over the entire course of the study.)