NCT01153841已完成3 期
Primary Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, in Healthy Infants in Vietnam When Co-administered With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
研究概览
简要总结
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
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
- None
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
- •Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •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.
- •Acute disease and/or fever at the time of enrolment.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
- •Hypersensitivity to latex.
- •Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
结局指标
主要结局
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
时间窗: Within the 31-day (Days 0-30) after each dose and across doses
The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.
次要结局
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period after each dose)
- Number of Subjects With Serious Adverse Events (SAEs)(After the first vaccination up to study end (From Month 0 to Month 3))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™Infections, StreptococcalStreptococcus Pneumoniae VaccinesNCT01641133GlaxoSmithKline457
已完成
3 期
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™Infections, StreptococcalStreptococcus PneumoniaeNCT00907777GlaxoSmithKline52
已完成
2 期
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.Pneumococcal ImmunizationNCT04583618Sanofi750
已完成
1 期
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)Pneumococcal ImmunizationNCT06698198Sanofi Pasteur, a Sanofi Company175
已完成
1 期
Study Evaluating Pneumococcal Vaccine in Healthy InfantsHealthy SubjectsPneumococcal InfectionsNCT00205803Wyeth is now a wholly owned subsidiary of Pfizer249