An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vabiotech
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
研究概览
简要总结
The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.
详细描述
This will be an open label, single group, bridging study. Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval.
This study was performed in strict accordance with Good Clinical Practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and enrollment
- •Subject born at full term of pregnancy (greater or equal to 37 weeks) and Birth weight ≥2500 grams
- •Weight ≥ 3,300 grams at the time of screeningSubject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator
- •Parent / legal representative can understand and be able to comply with the requirements of the protocol
- •Subjects born to mothers who are seronegative to HIV, HBV and HCV through a blood test or maternity record.
- •Parent / legal representative is willing to voluntarily sign the consent form for the participant
排除标准
- •History of diphtheria, tetanus, pertussis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically)
- •Fever (temperature ≥37.50C) or hypothermia (≤35.50C) or acute illness / infection that requires treatment.
- •Previous vaccination against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases.
- •Known allergy to any component of the vaccine;
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
- •Being treated with anticoagulants or at high risk of bleeding.
- •A family history of SIDS (sudden infant death syndrome)
- •Have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive therapy, radiation therapy in the last 4 weeks.
- •Have participated in another clinical trial within 30 days prior to the study vaccination or may participate in the course of the study.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects.
- •History of any neurological disorders or seizures
研究组 & 干预措施
Vaccination
DTPw-HB-Hib vaccine
干预措施: Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval (Biological)
结局指标
主要结局
Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
时间窗: Days 0 to 28 post-vaccination
次要结局
- Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration(Baseline to 30 minutes post-vaccination)