An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,274
- 主要终点
- Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
研究概览
简要总结
This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.
详细描述
In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.
In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.
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
- 12 Months 至 17 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
- •Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A
排除标准
- •Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
- •Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder
结局指标
主要结局
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
时间窗: 4 weeks postvaccination with PedvaxHIB™
Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate \[PRP\]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers \>1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
时间窗: 4 weeks postvaccination with Infanrix™
GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
Number of Participants With Adverse Events (AE)
时间窗: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs
Systemic and injection site AEs were collected from participants receiving * VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ administered alone (Stage II) Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Seropositivity Rate (SPR) to Hepatitis A
时间窗: 4 weeks after dose 2 of VAQTA™
SPR is the percent of participants with Hepatitis A antibody titers \>= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
次要结局
未报告次要终点