Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
研究概览
简要总结
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.
This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
详细描述
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 21 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between, and including, 18-21 months of age at the time of vaccination.
- •Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
- •Acute disease at the time of enrolment.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
研究组 & 干预措施
Synflorix Catch-up Group
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
干预措施: Infanrix Hexa (Biological)
Synflorix Catch-up Group
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
干预措施: Synflorix (Biological)
Synflorix Booster Group
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
干预措施: Havrix (Biological)
Synflorix Booster Group
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
干预措施: Infanrix Hexa (Biological)
Synflorix Booster Group
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
干预措施: Synflorix (Biological)
结局指标
主要结局
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
时间窗: Within 4 days after the administration of any study vaccine dose
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
次要结局
- Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
- Number of Subjects Reporting Solicited General Symptoms(Within 4 days after the administration of any study vaccine dose)
- Number of Subjects Reporting Unsolicited Adverse Events(Within 31 days after the administration of any study vaccine dose)
- Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study(Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose))
- Number of Subjects Reporting Solicited Local Symptoms(Within 4 days after the administration of any study vaccine dose)
- Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period(Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up))
- Anti-hepatitis A Virus Antibodies Concentration(Before (pre) and one month after (post) the administration of Dose 2)
- Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
- Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
- Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)