Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
研究概览
简要总结
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
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
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
- •Documented administration of a hepatitis B vaccine dose at birth
- •Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Born after a gestation period of at least 36 weeks
排除标准
- •The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- •Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
- •Concurrently participating in another clinical study, at any time during the study period, 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 and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Family history of congenital or hereditary immunodeficiency
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- •Major congenital defects or serious chronic illness
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- •Acute disease and/or fever at the time of enrolment
结局指标
主要结局
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
时间窗: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Hepatitis B (HBs)
时间窗: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
时间窗: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
时间窗: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
时间窗: One month post Dose 3 (Month 3 or Month 5)
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
次要结局
- Anti-D and Anti-T Antibody Concentrations(One month post Dose 3 (Month 3 or Month 5))
- Anti-HBs Antibody Concentrations(At Month 0)
- Anti-Polio Types 1, 2, 3 Antibody Titers(One month post Dose 3 (Month 3 or Month 5))
- Anti-PRP Antibody Concentrations(One month post Dose 3 (Month 3 or Month 5))
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At Month 0)
- Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN(At Month 0)
- Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens(At Month 0)
- Number of Seroprotected Subjects Against Anti-HBs Antigens(At Month 0)
- Anti-Polio Types 1, 2 and 3 Antibody Titers(At Month 0)
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group))
- Number of Subjects With Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)))