NCT00348881已完成3 期
Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,133
- 试验地点
- 4
- 主要终点
- Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
研究概览
简要总结
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •At Screening:
- •0 to 3 day old infants
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Apgar score ≥ 7 at three minutes after birth
- •Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- •At Inclusion:
- •Six weeks of age
- •Received a dose of Hepatitis B (HB) in the first three days of life
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •At Screening:
- •Illness at a stage that could interfere with trial conduct or completion
- •Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
- •Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
- •Acute illness on the day of screening.
- •At Screening and at Inclusion:
- •Blood or blood-derived products received since birth
- •Planned participation in another clinical trial during the present trial period
- •Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
- •Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- •Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
- •At Inclusion:
- •Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
- •Participation in another clinical trial before the first trial vaccination
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- •Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion
- •Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
- •Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
- •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 for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
时间窗: 1 month post third vaccination
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
时间窗: Day 0 to Day 7 post-vaccination
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
次要结局
- Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV(Day 0 to Day 7 after 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)
研究者
研究点 (4)
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