A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 385
- 主要终点
- Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
研究概览
简要总结
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
- To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
- To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule
Secondary objectives
- To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
- To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
- To describe the safety profile after each dose of study vaccines administered
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 46 Days 至 76 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant 46 to 74 days (both inclusive)
- •Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
- •Parent(s)/legal representative able to comply with the study procedures
排除标准
- •Participation in any study with an investigational compound or device since birth
- •History of congenital or acquired immunodeficiency
- •Chronic illness that could interfere with study conduct or completion
- •Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
- •Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
- •History or maternal history of HBsAg seropositivity
- •Coagulation disorder that contraindicate intramuscular injection
- •History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
- •History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
- •Receipt of immune globulin, blood or blood-derived products since birth
- •Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
研究组 & 干预措施
PR5I (V1); Pediacel® (V2); PR5I (V3)
[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
干预措施: Prevenar 13® (Biological)
PR5I (V1); Pediacel® (V2); PR5I (V3)
[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
干预措施: Pediacel® (Biological)
PR5I (V1); Pediacel® (V2); PR5I (V3)
[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
干预措施: NeisVac-C® (Biological)
PR5I (V1); Pediacel® (V2); PR5I (V3)
[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
干预措施: RotaTeq® (Biological)
PR5I (V1); Pediacel® (V2); PR5I (V3)
[Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
干预措施: PR5I (Biological)
结局指标
主要结局
Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
时间窗: Month 5 (one month after receiving Vaccination 3)
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
时间窗: Month 5 (one month after receiving Vaccination 3)
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
次要结局
- Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies(Month 3 (one month after receiving Vaccination 2))
- Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8(Month 3 (one month after receiving Vaccination 2))
- Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination(Up to Day 5 following each vaccination)
- Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Concentration of Antibodies to Diphtheria Toxin(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Concentration of Antibodies to Tetanus Toxin(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Concentrations of Antibodies to Pertussis Antigens(Month 5 (one month after receiving Vaccination 3))
- Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)(Month 5 (one month after receiving Vaccination 3))
- Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination(Up to Day 5 following each vaccination)
- Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination(Up to Day 5 following each vaccination)
- Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination(Up to Day 15 following each vaccination)
- Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination(Up to Day 15 following each vaccination)
- Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)(Up to Day 5 following each vaccination)
- Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)(Up to Day 15 following each vaccination)
- Number of Participants Experiencing a Serious Adverse Event (SAE)(Up to ~6 months (at any time during the study))