Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 798
- 试验地点
- 2
- 主要终点
- Number of Subjects With Fever >39°C (Rectal Route).
研究概览
简要总结
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
详细描述
Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.
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
- Single (Participant)
入排标准
- 年龄范围
- 427 Days 至 577 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- •Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
- •Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
研究组 & 干预措施
ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
干预措施: Tritanrix-HepB/Hib-MenAC (Biological)
ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hiberix (Biological)
ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hib-MenAC (Biological)
HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hiberix (Biological)
HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
干预措施: Tritanrix-HepB/Hib-MenAC (Biological)
ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hiberix (Biological)
ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hib-MenAC (Biological)
HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Tritanrix-HepB/Hiberix (Biological)
HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
干预措施: Mencevax-ACWY (Biological)
结局指标
主要结局
Number of Subjects With Fever >39°C (Rectal Route).
时间窗: During the 4-day (Day 0-3) follow-up period after booster vaccination
Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C.
次要结局
- Number of Subjects With Serious Adverse Events (SAEs).(From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C(During the 4-day (Day 0-3) follow-up period after vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Day 0-3) follow-up period after booster vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs).(During the 31-day (Day 0-30) following booster vaccination)