Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Immunogenicity with respect to components of the study vaccines.
研究概览
简要总结
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
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
- 2 Days 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •A male or female infant between, and including, 2 and 5 days of age at the time of randomisation.
- •Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive.
- •Subjects born to a mother seronegative for hepatitis B surface antigen.
- •Subjects with a birth weight >= 2.5 kg.
- •Subjects with a 5-minute Apgar score >=
- •Healthy subjects as established by medical history and clinical examination
排除标准
- •Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- •Born to a mother known or suspected to be seropositive for HIV.
- •Family history of congenital or hereditary immunodeficiency.
- •Children in care..
- •Neonatal jaundice requiring systemic treatment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Major congenital defects or serious chronic illness, including perinatal brain damage.
- •The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- •Current febrile illness or temperature >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
研究组 & 干预措施
Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: 251154 vaccine (Biological)
Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Synflorix™ (Biological)
Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Rotarix™ (Biological)
Group B
Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Synflorix™ (Biological)
Group B
Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Rotarix™ (Biological)
Group B
Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Infanrix hexa™ (Biological)
Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
干预措施: Infanrix hexa™ (Biological)
结局指标
主要结局
Immunogenicity with respect to components of the study vaccines.
时间窗: One month after the third dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines.
时间窗: One month after the first dose of primary vaccination.
次要结局
- Immunogenicity with respect to components of the study vaccines (on secondary readouts).(One month after booster vaccination.)
- Occurrence of solicited local and general symptoms (on secondary readouts).(On Day 0-Day 3 after each dose of primary and booster vaccination.)
- Occurrence of unsolicited adverse events (on secondary readouts).(On Day 0-Day 30 after each vaccination.)
- Occurrence of serious adverse events (on secondary readouts).(From enrolment up to study end.)
- Immunogenicity with respect to components of the study vaccines (on secondary readouts).(One month after the second dose of primary vaccination.)
- Immunogenicity with respect to components of the study vaccines (on secondary readouts).(One month after the third dose of primary vaccination.)
- Occurrence of solicited local and general symptoms (on secondary readouts).(On Day 0-Day 7 after neonatal vaccination.)