CTRI/2015/04/005688已完成1/2 期
A Phase I/II (Pilot) Trial to Evaluate the Safety and Immunogenicity of HBI Pentavalent (DTwP-Hb-Hib [Liquid]) Combination Vaccine in two groups of Healthy Subjects from 16 Months to 24 Months of Age and Two Years to Five Years of Age.
Human Biologicals Institute2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年11月4日最近更新:
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- 1.Proportion of the subjects experiencing local and/or systemic reactions.
研究概览
简要总结
A Phase I/II (Pilot) study to evaluate the safety and immunogenicity of HBI Pentavalent (DTwP-Hb-Hib[Liquid])Combination vaccine in two groups of Healthy Subjects from 16 months to 24 months of age and two years to Five years of age. The primary objective is to measure the Proportion of the subjects experiencing local and/or systemic reactions and the secondary objective is to measure the immunogenicity ( Seroconversion rate and Seroprotection rate) of the vaccine in both the age groups after a single booster dose. Blood samples will be collected from the subjects on visit 1 (before the vaccination) and at visit 2 (follow up visit after 4 -6 weeks) for estimation of antibodies. The samples will be sent to central lab at SRL for analysis. The study will be conducted in two centres in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy children between 16 months and five years of age who have not received booster dose or have received booster dose >1 year earlier 2.Subjects who have received primary immunization as per EPI schedule 3.Born after a normal gestational period (36 – 42 weeks) with a birth weight ≥2.5 kg 4.Judged to be in good health on the basis of reported medical history and history-directed physical examination 5.Plans to remain in the study area for the length of the trial 6.Parent or legally acceptable representative has provided Informed consent as per Schedule Y and Indian GCP guidelines.
排除标准
- •1.Participation in another clinical trial in the 4 weeks preceding the trial vaccination 2.Planned participation in another clinical trial during the present trial period 3.Infant born to known HIV I&II seropositive mother (documented laboratory result of HIV assay from the maternal blood sample is available) 4.Previous evidence of infection with Diphtheria, Tetanus, Pertussis Hepatitis B and H.
- •influenzae 5.History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics 6.Children having any intercurrent illness 7.Evidence of evolving neurological signs and symptoms 8.Known or suspected primary or acquired disease of the immune system 9.Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a “short course†of oral steroids, <7 days, as long as there are not two courses within the previous two weeks prior to vaccination) 10.Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction 11.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures 12.Receipt of blood products or immunoglobulin by mother in any trimester or by the child since birth 13.Daily use of non-steroidal anti-inflammatory drugs 14.Receipt of any vaccine other than OPV, BCG and or investigational product within the 30 days prior to enrollment, or planning to receive any other vaccine within 28 days after receiving study vaccine 15.Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath) 16.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine 17.History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis and Hepatitis B vaccine in a sibling 18.Thrombocytopenia or bleeding disorder that would pose as a contraindication to an IM vaccination.
结局指标
主要结局
1.Proportion of the subjects experiencing local and/or systemic reactions.
时间窗: Till 4 to 6 weeks after vaccination
2.Number of serious adverse events occurring.
时间窗: Till 4 to 6 weeks after vaccination
次要结局
- 1.Seroconversion rate and Seroprotection rate of HBI Pentavalent DTwP-Hb-Hib vaccine(4 to 6 weeks after vaccination)
研究者
研究点 (2)
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