NCT01171989已完成2 期
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 10
- 主要终点
- Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
研究概览
简要总结
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).
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
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- •Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- •A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
- •Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- •Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
- •Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
- •Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-
- •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.
- •The following adverse event having occurred after previous administration of DTP vaccine:
- •Encephalopathy.
- •Temperature of >= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
- •Collapse or shock-like state within 48 hours of vaccination.
- •Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
- •Seizures with or without fever occurring within 3 days of vaccination.
- •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:
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
结局指标
主要结局
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
时间窗: At Month 1, post-booster dose
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)
时间窗: At Month 1, post-booster dose
A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
次要结局
- Anti-rSBA-MenC Antibody Titres(At Month 0 and Month 1, before and one month after booster dose)
- Number of Seropositive Subjects for Anti-PRP(At Month 0, before the booster dose)
- Anti-HBs Antibody Concentrations(At Month 0 and Month 1, before and after booster dose)
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off(At Month 0 and Month 1, before and one month after booster dose)
- Anti-PRP Antibody Concentrations(At Month 0 and Month 1, before and one month after booster dose)
- Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(At Month 0 and Month 1, before and one month after booster dose)
- Number of Subjects With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-booster period)
- Number of Seroprotected Subjects Against rSBA-MenC(At Month 0, before the booster dose)
- Number of Seropositive Subjects for Anti-rSBA-MenC(At Month 0 and Month 1, before and one month after booster dose)
- Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values(At Month 0 and Month 1, before and one month after booster dose)
- Anti-PSC Antibody Concentrations(At Month 0 and Month 1, before and one month after booster dose)
- Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)(At Month 0 and Month 1, before and one month after booster dose)
- Anti-D and Anti-T Antibody Concentrations(At Month 0 and Month 1, before and one month after booster dose)
- Anti-poliovirus Types 1, 2 and 3 Antibody Titres(At Month 0 and Month 1, before and one month after booster dose)
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At Month 0 and Month 1, before and one month after booster dose)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-booster period)
- Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values(At Month 0 and Month 1, before and one month after booster dose)
- Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3(At Month 0 and Month 1, before and one month after booster dose)
- Number of Subjects With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-booster period)
- Number of Subjects With Serious Adverse Events (SAEs)(After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1))
研究者
研究点 (10)
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