Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 4
- 主要终点
- Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period
研究概览
简要总结
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.
详细描述
This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of at least 36 weeks.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any seizures or progressive neurological disease.
- •Administration of immunoglobulins and/or blood products since birth or planned use during the study.
- •Acute disease and/or fever at the time of enrolment.
- •Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
结局指标
主要结局
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period
时间窗: Within 31-day (Day 0-Day 30) after any dose of primary vaccination
The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.
次要结局
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period(During the 4-day (Days 0-3) post-vaccination period following each primary dose)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period(During the 4-day (Days 0-3) post-booster vaccination period)
- Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period(During the 31-day (Days 0-30) post-booster vaccination period)
- Number of Subjects With Unsolicited AEs - Booster Period(During the 31-day (Days 0-30) post-booster vaccination period)
- Number of Subjects With Serious Adverse Events (SAEs)(From first vaccination (Month 0) up to study end (11-14 months))
- Antibody Concentrations Against Pneumococcal Serotypes(At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination))
- Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes(At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period(During the 4-day (Days 0-3) post-vaccination period following each primary dose)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period(During the 4-day (Days 0-3) post-booster vaccination period)
- Number of Subjects With Unsolicited AEs - Primary Period(During the 31-day (Days 0-30) post-primary vaccination period)
- Concentrations of Antibodies Against Protein D (Anti-PD)(At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination))