Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 4
- 主要终点
- Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose
研究概览
简要总结
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.
The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
- •A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster 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 dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
- •Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT
- •Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT
- •History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Any of the following adverse events having occurred after previous administration of DTP vaccine:
- •Hypersensitivity reaction due to the vaccine.
- •Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
- •Any of the following adverse events having occurred after previous administration of DTP vaccine:
- •Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.
- •Collapse or shock-like state within 48 hours of vaccination.
- •Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.
- •Convulsions with or without fever, occurring within 3 days of vaccination
研究组 & 干预措施
Infanrix hexa Preservative-Free Formulation Group
Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
干预措施: Infanrix™ hexa (Biological)
Infanrix hexa Preservative-Containing Formulation Group
Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
干预措施: Infanrix™ hexa (Biological)
Infanrix penta Preservative-Free Formulation Group
Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.
干预措施: Infanrix™ penta (Biological)
结局指标
主要结局
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose
时间窗: One month after the booster dose
Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose
时间窗: One month after the booster dose
Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
时间窗: One month after the booster dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
时间窗: One month after the booster dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose
时间窗: One month after the booster dose
Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)
次要结局
- Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose(Before (Pre) and one month after (Post) the booster dose)
- Anti-HB Antibodies Concentration(Before (Pre) and one month after (Post) the booster dose)
- Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose(Before (Pre) and one month after (Post) the booster dose)
- Anti-PRP Antibodies Concentration(Before (Pre) and one month after (Post) the booster dose)
- Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose(Before the booster dose administration (at baseline))
- Anti-diphtheria and Anti-tetanus Antibodies Concentration(Before (Pre) and one month after (Post) the booster dose)
- Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose(Before (Pre) and one month after (Post) the booster dose)
- Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose(Before the booster dose administration (at baseline))
- Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose(Before the booster dose)
- Anti-poliovirus Antibodies Titer(Before (Pre) and one month after (Post) the booster dose)
- Number of Subjects Reporting Solicited Symptoms(Within the 4-day (Day 0-3) post-vaccination period)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(Within the 31-day (Day 0-30) post-vaccination period)
- Number of Subjects Reporting Serious Adverse Events (SAE)(Up to one month after the booster dose administration)