CTRI/2017/12/010803暂停2/3 期
A Phase II / III, prospective, randomised, active-controlled, open label, Parallel group, 2-arm, Multi-centric trial for evaluation of Efficacy, Safety, and Tolerability of DTaP plus Hib (Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b) combination vaccine in Indian paediatric population in comparison with Pentaxim® (Diphtheria, acellular Pertussis, Tetanus, Hemophilus influenza b and IPV) combination vaccine of Sanofi Pasteur
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- 暂停
- 入组人数
- 342
- 试验地点
- 5
- 主要终点
- 1) Seroconversion rate to each component
研究概览
简要总结
The study is being designed to evaluate Efficacy, Safety, and Tolerability of DTaP plus Hib (Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b) combination vaccine in Indian pediatric population in comparison with Pentaxim® (Diphtheria, acellular Pertussis, Tetanus, Hemophilus influenza b and IPV) combination vaccine of Sanofi Pasteur administered at 6, 10 and 14 weeks of age.
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
- 1.50 Month(s) 至 2.00 Month(s)（—）
- 性别
- All
入选标准
- •Full term (≥37 weeks) Indian children of either gender who have attained age ≥ 6 weeks
- •Subjects who are healthy as established by medical history & clinical examination and are eligible to receive primary immunization as per Universal Immunization Programme (UIP).
- •Parent or LAR of subject willing to give written informed consent and to comply to all study related procedures.
排除标准
- •1.Pre-term or Low birth weight children (≤ 2.5 kg at birth) 2.History of hypersensitivity to any of vaccines or vaccine components 3.History of any seizure / neurological or neuro-psychological disorder 4.Presence of congenital disorder /congenital infections or primary/acquired immuno-deficiency syndrome 5.Children with family history of congenital or hereditary immunodeficiency 6.History of exposure to immunosuppressive therapy after birth 7.History of HIV or HBV infection in the mother 8.Children who received blood or blood-derived products before enrolment 9.History of diphtheria, tetanus, pertussis, or Hemophilus influenza disease before enrolment or history of vaccination against diphtheria, tetanus, pertussis, or Hemophilus influenza 10.Planned administration of any other vaccine not foreseen by the study protocol within the period 30 days before inclusion or 30 days after the last dose of the vaccine except Rotavirus Vaccine, hepatitis B vaccine, Pneumococcal Conjugate Vaccine, Polio vaccine and any other vaccine given as a part of the national immunization schedule, allowed at that time of the study period.
- •11.Evidence of any chronic illness that could interfere with vaccine administration or evaluation 12.Planned or elective surgery during the study period.
- •13.Children suffering from acute febrile (> 38°C) illness / or acute non-febrile systemic illness in the past one week.
- •14.Children with thrombocytopenia/ bleeding disorder / any medical condition contraindicating intramuscular injections 15.Children diagnosed of blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems 16.Concurrent participation in any other trial at any time during the study period 17.Any other condition, which in the opinion of the investigator might interfere with the trial conduct and completion.
结局指标
主要结局
1) Seroconversion rate to each component
时间窗: 4 weeks after 3rd dose of vaccine
2) Change in Geometric mean titers (GMT) of antibody to each component
时间窗: 4 weeks after 3rd dose of vaccine
次要结局
- Incidence of adverse events / serious adverse events post vaccination(within 30 mins and 4 weeks post vaccination)
研究者
研究点 (5)
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