CTRI/2012/03/002490已完成3 期
A multicentric, phase III clinical trial to assess the immunogenicity and reactogenicity of ?Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed? administered to healthy infants at 6, 10 and 14 weeks of age.
Prosper Channel Life Science India Pvt Ltd0 个研究点目标入组 125 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy infants of 6(+4) weeks of age whose parents/legal guardians give written informed consent prior to the study entry.
- •Infants not seroprotected by immunization and/or disease (to any of the agents targeted by the DPT/DTPa vaccine)
排除标准
- •Evolving or changing neurological disorder
- •History of seizures
- •Fever 38°C in past 3 days
- •Acute illness or infection requiring systemic antibiotic therapywithin past 7 days
- •Previous disease potentially related to any of the agents targeted by the DPT vaccine
- •Impairment of the immune function, or
- •receiving or having received immunosuppressive
- •therapy within 1 month prior to study entry till completion
- •Received any blood or blood products, cytotoxic agents or radiotherapy
- •History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component
- •Chronic disease such as cardiac, autoimmune disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives.
- •Participated in another trial of an investigational agent within 30 days of enrolment
- •Infants whose families are planning to leave the area of the study site before the end of the study period.
研究者
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