A Phase IV, Multicentric, Controlled, Open labeled, Study to Evaluate the Safety and Immunogenicity of ComVac5 (DTwP-Hep-B-Hib-Liquid Pentavalent vaccine of BBIL) Vs. Reference Vaccine in healthy subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- To evaluate the safety and immunogenicity of ComVac-5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of BBIL) Versus reference WHO Pre-Qualified vaccine, in healthy subjects of age 6-8 weeks at time of enrollment as a non-inferiority trial.
研究概览
简要总结
The study will be a phase IV, multicentric randomized, controlled , open label, non-inferiority trial to assess safety and immunogenicity of the study vaccine versus the reference vaccine in healthy Indian children. A total of 300 needs to be vaccinated - 225 in the test arm and 75 in the control arm at the ratio of 3:1.The multicentric study will be at carried out at various centers in India. Primary Objective is to compare and demonstrate that the Immunogenicity and safety of the investigational product ComVac-5, is not clinically inferior to that of the WHO Pre-Qualified Reference Vaccine, in healthy subjects. Secondary Objective is Assessment of Safety: The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events ( local and systemic reactions) 4 weeks post vaccination with an intensive initial monitoring phase of 30 minutes post vaccination. Monitoring of safety would include all solicited and unsolicited AE and Vaccine consistency: To demonstrate lot to lot consistency between three different batches of the test vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures and visits.
- •Healthy male or female infant aged 6 to 8 weeks at the time of screening/enrollment.
- •Subjects who are healthy without any history of DTP and Hib vaccination.
- •(As Hepatitis B vaccination is often done at birth, history of immunization against Hepatitis B at birth is not a parameter for exclusion but the fact is recorded in the case record form).
- •Infant who is HBsAg negative.
- •Subjects should have been born after 36-week term and are not less than 3200 gms, at the time of inclusion.
排除标准
- •Fever of any origin of duration more than 3 days prior to/at screening visit.
- •Past history of DTP & Hib vaccination.
- •History of acute or chronic auto immune disease.
- •Any confirmed or suspected immunosuppressive condition.
- •Any treatment with immunosuppressive or immuno stimulant therapy 6)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP Hepatitis B and Hib.
- •Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
- •Known hypersensivity reactions to any of the components of the vaccine.
结局指标
主要结局
To evaluate the safety and immunogenicity of ComVac-5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of BBIL) Versus reference WHO Pre-Qualified vaccine, in healthy subjects of age 6-8 weeks at time of enrollment as a non-inferiority trial.
时间窗: 3 months
Immunogenicity
时间窗: 3 months
Seroconversion
时间窗: 3 months
Seroprotection
时间窗: 3 months
次要结局
- 1. Safety: monitoring of all local and systemic Adverse Events (solicited and unsolicited) following vaccination throughout the study period of 3 months.(2. To demonstrate lot to lot consistency between three different batch of test vaccine)