NCT00370227已完成3 期
To Assess Safety, Reactogenicity & Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine, Co-admin With GSK Biologicals' MMRV Vaccine in Children (2nd yr of Life) Primed With the Pneumococcal Conjugate Vaccine in Study 105553.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 8
- 主要终点
- Post vacc: rectal fever >39°C
研究概览
简要总结
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age.
The study has 3 groups.
- The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of MMRV vaccine at 14-16 mo of age.
- The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of MMRV vaccine at 14-16 mo of age.
- The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.
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
- 12 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
排除标准
- •use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
- •Administration of any additional pneumococcal vaccine since end of study
- •Previous vaccination against measles, mumps, rubella and/or varicella. History of, or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
- •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
- •Immunosuppressive or immunodeficient condition.
- •A history of seizures or neurological disease.
结局指标
主要结局
Post vacc: rectal fever >39°C
次要结局
- AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens.
研究者
研究点 (8)
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