A Phase 4 Randomized OpenLabel Trial to Describe the Safety Tolerability and Immunogenicity of 13 Valent Pneumococcal Conjugate Vaccine Formulated in Multidose Vials When Given With Routine Pediatric Vaccines in Healthy Infants in India.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- To describe the safety profile of 13vPnC with 2-PE in the MDV group and without 2-PE in the PFS group
研究概览
简要总结
This is a phase 4, randomized, open label trial to describe the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) formulated in multidose vials when given with routine pediatric vaccines in healthy infants in India. This study is being conducted in response to a post approval marketing authorization condition by the Drugs Controller General of India (DCGI) vide letter 27-Jun-2016. Currently 13vPnC is available as a single dose prefilled syringe. Now Pfizer has developed a formulation containing the preservative 2-phenoxyethanol (2-PE) that will allow the vaccine to be supplied in a multi-dose vial presentation with 4 doses per vial. The multi-dose vial presentation with 2-PE will help significantly reduce the cold-chain requirements, storage costs and wastage incurred in delivering the vaccine through large scale public immunization programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 72.00 Day(s)（—）
- 性别
- All
入选标准
- •Evidence of a personally signed and dated informed consent document indicating that the parent(s)or legal guardian(s) has or have been informed of all pertinent aspects of the study.
- •Parent(s) or legal guardian(s) or caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •Aged 6 weeks (42 to 72 days) at the time of vaccination.
- •(The day of birth is considered Day 0) 4.Available for the entire study period and whose parent(s) or legal guardian(s) or caregiver(s) can be reached by telephone.
- •Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
排除标准
- •Infant who is a direct descendant (child, grandchild) of • Investigator site staff members directly involved in the conduct of the study, or • Site staff members otherwise supervised by the investigator, or • Pfizer employees directly involved in the conduct of the study.
- •Participation in other studies involving investigational drug(s) within 28 days prior to study entry and or during study participation.
- •Participation in purely observational studies is acceptable.
- •Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
- •Major known congenital malformation or serious chronic disorder.
- •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’s palsy.
- •Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
- •Inclusion and exclusion criteria for participant selection, including age and sex.
- •Age and sex to be mentioned in specific boxes.
结局指标
主要结局
To describe the safety profile of 13vPnC with 2-PE in the MDV group and without 2-PE in the PFS group
时间窗: From 6 week visit to 1 month after the infant series (13 Month visit)
Primary Endpoint:
时间窗: From 6 week visit to 1 month after the infant series (13 Month visit)
1. Incidence of local reactions and systemic events, Adverse events, serious adverse events and Incidence of newly diagnosed chronic medical conditions at defined time periods in the MDV group and in the PFS group
时间窗: From 6 week visit to 1 month after the infant series (13 Month visit)
次要结局
- To describe the pneumococcal immune responses(induced by 13vPnC with 2-PE in the MDV group and in the PFS group)