A Phase 3, Randomized, Active-controlled, Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13vpnc Compared With A 7vpnc In Healthy Infants In China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,674
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
研究概览
简要总结
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
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
- 42 Days 至 77 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
- •Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
排除标准
- •Previous vaccination with licensed or investigational pneumococcal vaccine.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with pneumococcal vaccines.
研究组 & 干预措施
13vPnC (3-, 5-, 12-Month)
干预措施: 13-valent Pnumococcal Conjugate vaccine (Biological)
7vPnC (3-, 4-, 5-, 12-Month)
干预措施: 7-valent Pneumococcal Conjugate Vaccine (Biological)
13vPnC (3-, 4-, 5-, 12-Month)
干预措施: 13-valent Pnumococcal Conjugate vaccine (Biological)
13vPnC (2-, 4-, 6-, 12-Month)
干预措施: 13-valent Pnumococcal Conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
时间窗: 1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
时间窗: 1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
时间窗: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
时间窗: 1 month after the infant series (7 Months of age)
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
时间窗: Approximately 16 months from the participation into the study to the end of study
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
时间窗: Approximately 16 months from the participation into study to the end of study
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
时间窗: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
时间窗: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
时间窗: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
时间窗: Seven days after each pneumococcal vaccination dose within the period up to 12 months
次要结局
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.(1 month after the toddler dose (13 Months of age))
- Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.(1 month after the infant series (6 Months of age))
- Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.(1 month after the toddler dose (13 Months of age))
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.(1 month after the infant series (6 Months of age))
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.(1 month after the toddler dose (13 Months of age))
- Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.(1 month after the infant series (6 Months of age))
- Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.(1 month after the infant series (7 Months of age))
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.(1 month after the infant series (6 Months of age))
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.(1 month after the infant series (7 Months of age))
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.(1 month after the toddler dose (13 Months of age))
- Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.(1 month after the toddler dose (13 Months of age))
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.(1 month after the toddler dose (13 Months of age))
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.(1 month after the infant series (6 Months of age))
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.(1 month after the infant series (6 Months of age))