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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Anti-PT, anti-FHA, anti-diphtheria and anti-tetanus antibody concentrations.
研究概览
简要总结
This study is multricentric 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 that will be conducted at 2 centers in India. Primary outcome measures will be assessment of immunogenicity 1 month after the three dose primary vaccination series. The secondary outcome will be occurrence of solicitated and unsolicitated local and general adverse events during the 4 day follow up period after vaccination, during follow up and during entire study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 42.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
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 Preterms 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.
结局指标
主要结局
Anti-PT, anti-FHA, anti-diphtheria and anti-tetanus antibody concentrations.
时间窗: one month after a three-dose primary vaccination course.
Seroprotection status defined as anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/ml.
时间窗: one month after a three-dose primary vaccination course.
Seroprotection defined for pertussis will be anti-PT, anti-FHA concentrations ≥ 5 EL.U/ml.
时间窗: one month after a three-dose primary vaccination course.
次要结局
- Occurrence of solicited local adverse events
- Occurrence of solicited general adverse events(During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination)
- Occurrence of unsolicited local and general adverse events(On follow up)
- Occurrence of serious adverse events(During entire study)