Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 2
- 主要终点
- Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
研究概览
简要总结
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
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
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0 to 3 day old infants
- •Mother seronegative for Human Immunodeficiency Virus (HIV)
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Apgar score >7 at 5 or 10 minutes of life
- •Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Current or planned participation in another clinical trial during the entire duration of the present trial
- •Suspected congenital or acquired immunodeficiency
- •Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
- •Chronic illness at a stage that could interfere with trial conduct or completion
- •Blood or blood-derived products received since birth
- •Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
- •Oral Poliovirus Vaccine (OPV) administration at birth
- •Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- •History of seizures
- •Febrile or acute illness on the day of inclusion.
结局指标
主要结局
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
时间窗: 1 month post-Dose 3
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).
次要结局
- Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)(1 month post-Dose 3)
- Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)(Day 42 before Dose 1 and 1 month post-Dose 3)
- Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV(Day 540 pre-booster and Day 570, post-booster)
- Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV(Day 540 pre-booster and Day 570 post-booster)
- Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).(Day 0 up to Day 7 post each dose)
- Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)(Day 0 up to 7 post-booster vaccination)