Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,189
- 试验地点
- 6
- 主要终点
- Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
研究概览
简要总结
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.
The secondary objectives are:
- To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
- To assess the overall safety in each group one month after the third dose of the primary series.
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
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two months old infants on the day of inclusion
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Informed consent form signed by one or both parents or by the guardian and two independent witnesses
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
排除标准
- •Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency
- •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
- •Blood or blood-derived products received since birth
- •Any vaccination in the four weeks preceding the first trial visit
- •Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
- •Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- •Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
- •Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of seizures
- •Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
研究组 & 干预措施
Group 1
Participants receive vaccine Batch A
干预措施: DTaP-IPV-HB-PRP~T vaccine (Biological)
Group 2
Participants receive vaccine Batch B
干预措施: DTaP-IPV-HB-PRP~T vaccine (Biological)
Group 3
Participants receive vaccine Batch C
干预措施: DTaP-IPV-HB-PRP~T vaccine (Biological)
Group 4
Participants receive Infanrix hexa™
干预措施: DTaP-HBV-IPV vaccine (Biological)
结局指标
主要结局
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
时间窗: Day 150 (one month post-dose 3)
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
时间窗: Day 150 (one month post-dose 3)
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
时间窗: Day 150 (one month post-dose 3)
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
次要结局
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine(Day 0 (pre-each vaccination) up to 7 days post-each dose)
- Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine(Day 150 (one month post-dose 3))