Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,167
- 试验地点
- 23
- 主要终点
- Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
研究概览
简要总结
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
详细描述
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
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
- •Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
- •Infants with at least 36 weeks of gestation at delivery.
- •Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
- •Able to attend the scheduled visits and to comply with the study procedures.
- •Parent or legal guardian willing to take rectal temperatures during the infant series.
- •Parent or legal guardian has access to a telephone.
- •Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
- •Able to obtain at least 1.5 mL of blood sample prior to Dose 1.
排除标准
- •Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- •Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- •Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- •Known Human Immunodeficiency Virus (HIV)-positive mother or child.
- •Personal or immediate family history of congenital immune deficiency.
- •Developmental delay or neurologic disorder.
- •Chronic medical, congenital, or developmental disease.
- •Participation in any other clinical trial.
- •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.
- •Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
研究组 & 干预措施
Pentacel™ concurrently with Prevnar®
Participants had Pentacel™ concurrently administered with Prevnar®
干预措施: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® (Biological)
Pentacel™ staggered schedule with Prevnar®
Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
干预措施: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® (Biological)
结局指标
主要结局
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
时间窗: 28 to 48 days post-3rd vaccination
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
时间窗: 60 Days Post-dose 3
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
次要结局
未报告次要终点