A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy 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
- 2,808
- 主要终点
- Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
研究概览
简要总结
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
详细描述
This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Lot A
V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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 Lot C
V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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 Lot A
V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot A
V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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 Lot A
V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot B
V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot B
V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot B
V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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 Lot B
V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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 Lot C
V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot C
V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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)
V419 Lot C
V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
干预措施: PENTACEL™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
干预措施: Prevnar 13™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
干预措施: RotaTeq™ (Biological)
Control
Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
干预措施: Recombivax HB vaccine (Biological)
结局指标
主要结局
Geometric Mean Concentration of Antibodies 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.
Geometric Mean Concentration of Antibodies 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. The unit of measure is International Units/mL (IU/mL).
Geometric Mean Concentration of Antibodies 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. The unit of measure is milli International Units/mL (mIU/mL).
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Geometric Mean Titer for Antibodies 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. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
Geometric Mean Concentration of Antibodies to Pertussis Toxin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
Geometric Mean Concentration of Antibodies to Tetanus Toxin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
时间窗: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Geometric Mean Titer for Antibodies 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.
Geometric Mean Titer for Antibodies 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.
次要结局
- Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen(Postdose 3 (Month 7))
- Percentage of Participants Responding to Tetanus Toxin(Postdose 3 (Month 7))
- Percentage of Participants Responding to Poliovirus Type 1(Postdose 3 (Month 7))
- Percentage of Participants Responding to Poliovirus Type 2(Postdose 3 (Month 7))
- Geometric Mean Concentration of Antibodies to Pertussis Toxin(Postdose 4 (Month 16))
- Geometric Mean Concentration of Antibodies to Pertussis Fimbriae(Postdose 4 (Month 16))
- Percentage of Participants Responding to Diphtheria Toxin(Postdose 3 (Month 7))
- Percentage of Participants Responding to Pertussis Toxin(Postdose 4 (Month 16))
- Percentage of Participants Responding to Pertussis Fimbriae(Postdose 4 (Month 16))
- Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin(Postdose 4 (Month 16))
- Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions(Up to 5 days after any infant vaccination (up to 6 months))
- Geometric Mean Concentration of Antibodies to Pertussis Pertactin(Postdose 4 (Month 16))
- Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes(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 Responding to Pertussis Filamentous Hemagglutinin(Postdose 4 (Month 16))
- Percentage of Participants Responding to Hepatitis B Surface Antigen(Postdose 3 (Month 7))
- Percentage of Participants Responding to Pertussis Pertactin(Postdose 4 (Month 16))
- Percentage of Participants Responding to Poliovirus Type 3(Postdose 3 (Month 7))