EUCTR2012-004039-21-Outside-EU/EEA进行中（未招募）不适用
An open, multicentric, post-marketing surveillance study to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when administered according to the Prescribing Information, in Filipino subjects aged at least 6 weeks at the time of first vaccination. - Rota-043
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,439
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A Filipino male or female aged at least 6 weeks at the time of first vaccination.
- •Written informed consent was to be obtained from the parent(s)/ or guardian(s) of each the subject
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1439
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract.
- •Any contraindications as stated in the Prescribing Information (PI).
研究者
相似试验
进行中（未招募）
不适用
An open, multicentric, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infantsHealthy volunteers (Primary immunization of healthy infants at 3, 4 and 5 months of age with a booster dose at 18 months of age, against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b diseases).EUCTR2015-001512-35-Outside-EU/EEAGlaxoSmithKline Biologicals4,500
进行中（未招募）
不适用
A PMS study to assess the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib and INFANRIX HEXA™ vaccines when administered as a primary vaccination course, followed by admini-stration of GSK Biologicals’ DTPa-IPV/Hib vaccine as a booster dose in toddlers.EUCTR2012-002439-26-Outside-EU/EEAGlaxoSmithKline Biologicals702
进行中（未招募）
不适用
Evaluation of reactogenicity and safety of GSK Biologicals’ Rotarix (human rotavirus vaccine) in infants.Rotavirus GastroenteritisEUCTR2015-001546-28-Outside-EU/EEASmithkline Beecham Pvt Limited522
尚未招募
4 期
Tofacitinib Tablets in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative ColitisCTRI/2024/07/071353Sun Pharmaceutical Industries Limited (SPIL)
尚未招募
4 期
Enzobiotics Post Marketing surveillance studyCTRI/2024/07/071372Mylin Biotech India Private Limited