A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,473
- 主要终点
- Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
研究概览
简要总结
This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.
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
- 46 Days 至 89 Days（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
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: RotaTeq™ (Biological)
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: V419 (Biological)
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: DAPTACEL™ (Biological)
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: PedvaxHIB™ (Biological)
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: Prevnar 13™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: DAPTACEL™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: Prevnar 13™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: RotaTeq™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: PENTACEL™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: Recombivax HB vaccine (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
干预措施: ActHIB™ (Biological)
结局指标
主要结局
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Percentage of Participants Responding to Pertussis Pertactin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Percentage of Participants Responding to Pertussis Fimbriae
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Percentage of Participants Responding to Poliovirus Type 1
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Percentage of Participants Responding to Poliovirus Type 2
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \>=8.
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer \>=0.15 μg/mL and \>=1.0 μg/mL.
Percentage of Participants Responding to Hepatitis B Surface Antigen
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 milli International units (mIU)/mL.
Percentage of Participants Responding to Diphtheria Toxin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 International unit (IU)/mL.
Percentage of Participants Responding to Tetanus Toxin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Percentage of Participants Responding to Pertussis Toxin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Percentage of Participants Responding to Poliovirus Type 3
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \>=8.
Geometric Mean Concentration of Antibodies to Pertussis Toxin
时间窗: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
次要结局
- Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions(Up to 5 days after any infant vaccination (up to 6 months))
- Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug(Up to 5 days after each infant vaccination (up to 6 months))
- Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen(Postdose 3 (Month 7))
- Percentage of Participants With Elevated Temperature by Severity(Up to 5 days after any infant vaccination (up to 6 months))
- Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion(Up to 181 days after any infant vaccination (up to 12 months))
- Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus(Postdose 3 (Month 7))