A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 9
- 主要终点
- Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged from 7 months to <72 months at time of enrollment.
- •Available for entire study period and whose parent/legal guardian could be reached by telephone.
- •Healthy as determined by medical history, physical examination, and judgment of the investigator.
- •Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.
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 vaccine.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Known or suspected immune deficiency or suppression.
- •History of culture-proven invasive disease caused by S pneumoniae.
- •Major known congenital malformation or serious chronic disorders.
- •Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
- •Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
- •Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- •Child is a direct descendant (child or grandchild) of a member of the study site personnel.
结局指标
主要结局
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
时间窗: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
时间窗: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
次要结局
- Percentage of Participants Reporting Pre-Specified Local Reactions(During the 4-day period after each dose)
- Percentage of Participants Reporting Pre-Specified Systemic Events(During the 4-day period after each dose)