Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- To provide information concerning the safety of PENTAXIM™ Vaccine.
研究概览
简要总结
The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.
WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.
To assess the safety of Pentaxim.
详细描述
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:
Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.
Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.
All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
- •Healthy male or female newborn
- •Age ranging from birth to 48 hours of life (included)
- •Birth weight >2.5 kg and gestational age >37 weeks
- •Born to HBs antigen-negative mother
排除标准
- •Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
- •Infant presently enrolled or scheduled to be enrolled in another clinical trial
- •Infant with moderate or severe illness, mainly infectious diseases
- •Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
- •Infant with severe congenital defects or abnormalities
- •Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Known immunological deficiency (including a known HIV seropositive mother)
- •Administration of vaccine since birth (other than BCG)
- •Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)
结局指标
主要结局
To provide information concerning the safety of PENTAXIM™ Vaccine.
时间窗: 20 months
次要结局
未报告次要终点