Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,167
- 试验地点
- 36
- 主要终点
- Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
研究概览
简要总结
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
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
- 42 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 42 days and ≤ 89 days on the day of inclusion
- •Born at full term of pregnancy (≥ 36 weeks)
- •Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
- •Vaccination with a hepatitis B vaccine at least 30 days before inclusion
- •Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
- •Provide blood sample prior to Dose 1
- •Parent or legal representative willing to take rectal temperatures after each vaccination.
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
- •Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
- •Chronic illness that could interfere with trial conduct or completion
- •Received blood or blood-derived products since birth
- •Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
- •Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
- •Coagulation disorder contraindicating intramuscular (IM) vaccination
- •Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
- •Developmental delay or neurological disorder
- •Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
研究组 & 干预措施
Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
干预措施: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. (Biological)
Study Group 2: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
干预措施: Pentacel®: DTaP-IPV/Hib combined (Biological)
Study Group 3: DTaP-IPV and ActHIB®
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
干预措施: DTaP-IPV and ActHIB® (Biological)
Study Group 4: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
干预措施: Pentacel®: DTaP-IPV/Hib combined (Biological)
结局指标
主要结局
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
时间窗: 30 Days post-dose 3 vaccination
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
时间窗: 30 Days post-dose 3 vaccination
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
时间窗: 30 Days post-dose 3 vaccination.
次要结局
未报告次要终点