Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
研究概览
简要总结
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.
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
- 6 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese participant
- •Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1
排除标准
- •History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
- •Gastrointestinal disorder, growth retardation, or failure to thrive
- •History of intussusception
- •Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
- •Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
- •Cardiovascular, renal, liver, or blood disease
- •History of convulsion
- •Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
- •Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine
- •Live vaccine received within 28 days or inactivated vaccine received within 7 days
- •At high risk for tuberculosis exposure
研究组 & 干预措施
Concomitant RotaTeq™ and DTP-IPV
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
干预措施: RotaTeq™ (V260) (Biological)
Concomitant RotaTeq™ and DTP-IPV
RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
干预措施: DTP-IPV (Biological)
Staggered RotaTeq™ and DTP-IPV
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
干预措施: RotaTeq™ (V260) (Biological)
Staggered RotaTeq™ and DTP-IPV
RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
干预措施: DTP-IPV (Biological)
结局指标
主要结局
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
时间窗: 4 to 6 weeks after the third dose of DTP-IPV
Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, \>=0.1 International Units (IU)/mL; Tetanus Toxin, \>=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, \>=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer \>=8.
次要结局
- Percentage of Participants Reporting an Adverse Event With Incidence >=1%(Up to 14 days after any of the 6 study visits)
- Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea(Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit))
- Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events(Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit))
- Geometric Mean Titers for Diphtheria Toxin Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Geometric Mean Titers for Tetanus Toxin Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Percentage of Participants Reporting an Adverse Event of Special Interest: Fever(Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit))
- Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting(Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit))
- Geometric Mean Titers for Pertussis Toxin Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Geometric Mean Titers for Pertussis FHA Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Geometric Mean Titers for Poliovirus Type 1 Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Geometric Mean Titers for Poliovirus Type 2 Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)
- Geometric Mean Titers for Poliovirus Type 3 Antibody(Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV)