Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (Shan6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 3
- 主要终点
- Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
研究概览
简要总结
Primary Objective:
To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV
Secondary Objective:
- To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV)
- To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group
- To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group
- To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV
- To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™
- To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines
详细描述
The duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days)
in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation 10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131 Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
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
- 8 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A - Intervention regimen
SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine [PCV] [Prevnar 13®] and oral rotavirus vaccine [ORV-1] [Rotarix™] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months
干预措施: DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus) (Biological)
Group A - Intervention regimen
SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine [PCV] [Prevnar 13®] and oral rotavirus vaccine [ORV-1] [Rotarix™] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months
干预措施: Human Rotavirus, live attenuated (Biological)
Group A - Intervention regimen
SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine [PCV] [Prevnar 13®] and oral rotavirus vaccine [ORV-1] [Rotarix™] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months
干预措施: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus) (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: Inactivated Poliomyelitis Vaccine (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: Poliomyelitis Vaccine bivalent types 1 and 3 (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: Human Rotavirus, live attenuated (Biological)
Group B - Control regimen
SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
干预措施: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (Biological)
结局指标
主要结局
Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
时间窗: 28 days after the third dose (Day 148)
Ab against pertussis antigens will be measured
Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens
时间窗: 28 days after the third dose (Day 148)
Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
次要结局
- Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens(At baseline (Day 0) and 28 days after the third dose (Day 148))
- Number of participants with a vaccine response for pertussis antigens(At baseline (Day 0) and 28 days after the third dose (Day 148))
- Pertussis antigens vaccine seroconversion(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants(At baseline (Day 0) and 28 days after the third dose (Day 148))
- GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants(At baseline (Day 0) and 28 days after the third dose (Day 148))
- Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants(At baseline (Day 0) and 28 days after the third dose (Day 148))
- Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants(At baseline (Day 0) and 28 days after the third dose (Day 148))
- Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- Number of participants with a booster response for pertussis antigens(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- GMCRs of Ab against all the antigens(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- GMCs of Ab against each antigen(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- aGMCs of Ab against pertussis antigens(Before and 28 days after the booster dose (at Day 388-478 and Day 416-506))
- Number of participants reporting immediate systemic adverse events (AEs)(Within 30 minutes post-vaccination)
- Number of participants reporting solicited injection site and systemic reactions(Up to 7 days post-vaccination)
- Number of participants reporting unsolicited non-serious AEs(Up to 28 days post-vaccination)
- Number of participants reporting serious adverse events (SAEs)(Up to Day 416-506)