Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
研究概览
简要总结
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
详细描述
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
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 (Care Provider)
入排标准
- 年龄范围
- 427 Days 至 730 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female between and including 15 and 24 months of age
- •Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
排除标准
- •Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
- •History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
研究组 & 干预措施
ACAC GROUP
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months 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 GROUP
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months 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)
HibACPS GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months 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)
HibHibPS GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months 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)
CC GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months 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/Hiberix (Biological)
CC GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months 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: Meningitec (Biological)
HibHibPS GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months 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 GROUP
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months 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)
ACHibPS GROUP
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months 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
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
时间窗: One month Post-Booster vaccination at 15-24 months of age
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
时间窗: One Month Post-Booster vaccination at 15-24 months of age
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
时间窗: One Month Post-Booster vaccination at 15-24 months of age
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
次要结局
- Anti-PSA Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values(One month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-TT Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-SBA-MenC Antibody Titers(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0 to Day 3) post-vaccination period)
- Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-PRP Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-rSBA-MenA Antibody Titers(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-BPT Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-HBs Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Anti-D Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period)
- Anti-PSC Antibody Concentrations(Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age)
- Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value(One month Post-Booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Up to one month Post-Booster vaccination)