NCT00169507已完成3 期
Phase III Multicentric Open Study to Evaluate Immunological Memory Induced by 3-dose Primary Vaccination Followed by Booster Dose of GSK Biologicals' 11-valent Conjugate Pneumococcal Vaccine Compared to Unprimed Subjects by Giving 1 Dose of Aventis Pasteur's Pneumo 23
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).
研究概览
简要总结
Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.
详细描述
Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 31 Months 至 57 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female who participated in Undeca-Pn-010 study, were part of the blood subset and received 4 doses of GSK Biologicals' 11Pn-PD vaccine, or Havrix vaccine.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)
结局指标
主要结局
Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).
次要结局
- Before Pneumo 23 administration: Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F & seropositivity (S+) status* (>= 0.05 µg/mL) * also measured 10-15 days after dose of Pneumo 23
- Occurrence of SAEs during study period
- Before and 10-15 days after dose of Pneumo 23: Antibody titers (opsono) to selected pneumococcal serotypes and S+ status (>= 8)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
3 期
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate VaccineInfections, StreptococcalStreptococcus Pneumoniae VaccinesNCT00307541GlaxoSmithKline120
已完成
4 期
A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 Vaccine Revaccinations in the ElderlyVaccinationNCT04701788China National Biotec Group Company Limited331
Unknown
4 期
Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal VaccineMeningococcal Disease Meningococcal MeningitisNCT00262015Chiron Corporation264
已完成
3 期
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine BoostingStreptococcus PneumoniaeHIV InfectionsNCT00622843Henry M. Jackson Foundation for the Advancement of Military Medicine275
已完成
3 期
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In ChinaPneumococcal InfectionNCT01692886Pfizer1,674