NCT00307541已完成3 期
Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 32
- 主要终点
- 1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
研究概览
简要总结
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
详细描述
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
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
- Single
入排标准
- 年龄范围
- 8 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems 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 first dose of study vaccine, or planned use during the study period.
- •Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
结局指标
主要结局
1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
次要结局
- Ab concns to protein D and seropositivity (S+) status
- Antibody (Ab) concns >= 0.05 µg/mL
- S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
- After each vaccination, occurrence of: solicited local, general symptoms within 4 days
- Unsolicited adverse events within 31 days, SAEs (whole study period)
- 1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
研究者
研究点 (32)
Loading locations...
相似试验
已完成
3 期
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In ChinaPneumococcal InfectionNCT01692886Pfizer1,674
已完成
3 期
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose ScheduleInfections, StreptococcalNCT00307034GlaxoSmithKline351
已完成
3 期
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine BoostingHIV InfectionsStreptococcus PneumoniaeNCT00622843Henry M. Jackson Foundation for the Advancement of Military Medicine275
已完成
3 期
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.Pneumococcal Disease13-valent Pneumococcal VaccineNCT00743652Pfizer373
已完成
3 期
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in AdultsPneumococcal InfectionsNCT00427895Pfizer2,141