NCT01738841撤回不适用
Post-marketing Surveillance Study of GSK Biologicals' Live, Attenuated Measles, Mumps, Rubella and Varicella Vaccine, Priorix-Tetra, Following a Single Vaccine Dose Given According to Local Prescribing Information in the Philippines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
研究概览
简要总结
This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines.
详细描述
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 12 Years（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.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination.
- •Female subjects of child bearing potential may be enrolled in the study, if the subject:
- •has agreed to be abstinent or practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the vaccination.
排除标准
- •Child in care.
- •Any contraindications to vaccination as stated in the Prescribing Information.
- •Acute, severe febrile illness at the time of enrollment. The presence of a minor infection, such as a cold, will not exclude the subject from the study.
- •Previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry.
- •Previous enrolment in this trial.
- •Subjects with impaired immune function, including primary or secondary immunodeficiencies based on medical history.
- •History of hypersensitivity to any component of the vaccine.
- •History of hypersensitivity following previous administration of measles, mumps, rubella and/or varicella-virus containing vaccines.
- •Receipt of human gamma globulins or a blood transfusion within 3 months prior to study entry.
- •Hypersensitivity to latex.
- •Pregnant or lactating female.
结局指标
主要结局
Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
时间窗: Between Day 0 and Day 42
次要结局
- Occurrence of Serious Adverse Events (SAEs)(From the time of vaccination (Week 0) to study end (Week 6))
- Occurrence of febrile convulsions(Between Day 0 and Day 42)
- Occurrence of Grade 3 AEs(Between Day 0 and Day 42)
- Occurrence of medically-attended AEs(Between Day 0 and Day 42)
研究者
相似试验
终止
4 期
A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.Human Papillomavirus Infection Leading to Cervical CancerNCT00730847GlaxoSmithKline743
撤回
不适用
Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri LankaHuman Papillomavirus InfectionNCT01551537GlaxoSmithKline
已完成
3 期
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of AgeMeasles-Mumps-RubellaNCT01621802GlaxoSmithKline4,011
已完成
4 期
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.MeaslesMumpsRubellaNCT00388440GlaxoSmithKline150
已完成
不适用
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and AboveInfluenzaNCT05406180Sanofi675