Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,375
- 试验地点
- 2
- 主要终点
- Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™
研究概览
简要总结
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
- To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
- To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.
Secondary Objectives:
- To describe in each group the immunogenicity parameters for all antigens for each vaccine
- To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.
详细描述
Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.
All participants will be monitored for safety for 6 months after the last injection of the primary vaccination 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Days 至 65 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two month old infants (55 to 65 days old) 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 legally acceptable representative as per local requirements.
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines 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 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
- •Known 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, in the opinion of the Investigator.
- •Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
- •Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
- •Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
- •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 pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
- •Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
- •Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
- •History of seizures or encephalopathy.
- •Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.
研究组 & 干预措施
Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)
干预措施: DTaP-IPV-Hep B-PRP-T Vaccine (Biological)
Group 4: Active Control
干预措施: DTaP-Hep B-IPV vaccine (Biological)
Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)
干预措施: DTaP-IPV-Hep B-PRP-T Vaccine (Biological)
Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)
干预措施: DTaP-IPV-Hep B-PRP-T Vaccine (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™
时间窗: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination
Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
时间窗: 30 Days post-dose 3
Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
次要结局
- Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine(Day 0 (pre-vaccination) and 30 days post-dose 3)
- Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine(Day 0 up to 7 after each dose)
- Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine(Day 0 up to 7 post each vaccination)