NCT00343889已完成3 期
Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 2
- 主要终点
- Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
研究概览
简要总结
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
The primary objective is:
- To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.
The secondary objectives are:
- To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
- To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 50 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
- •Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- •Chronic illness at a stage that could interfere with the conduct or completion of the trial
- •Blood or blood-derived products received since birth
- •HB vaccination since birth
- •Any vaccination in the four weeks preceding the first trial vaccination
- •Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
- •Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
- •Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
- •History of seizures
- •Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
结局指标
主要结局
Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
时间窗: 1 month post third vaccination
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.
次要结局
- Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV(1 month post third vaccination)
- Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV(1 month post third vaccination)
- Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV(1 month post third vaccination)
- Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV(1 month post third vaccination)
- Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV(Day 0 up to Day 7 after each vaccination)
研究者
研究点 (2)
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