NCT02174705Unknown3 期
A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
Anna Taddio2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Distress
研究概览
简要总结
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life
排除标准
- •impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial
研究组 & 干预措施
Sucrose
Experimental
Sucrose prior to vaccine injections
干预措施: Sucrose (Drug)
Rotavirus
Active Comparator
Rotavirus prior to vaccine injections
干预措施: Rotavirus (Drug)
结局指标
主要结局
Distress
时间窗: immediately after vaccinations in 15 seconds
Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall
次要结局
- Distress(immediately after vaccinations in 1 minute)
研究者
Anna Taddio
Professor
University of Toronto
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe GastroenteritisInfections, RotavirusNCT01978223GlaxoSmithKline
已完成
1 期
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus VaccineRotavirus InfectionNCT01764256PATH48
已完成
3 期
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy InfantsInfections, RotavirusNCT00197210GlaxoSmithKline10,708
已完成
1 期
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male VolunteersRotavirus GastroenteritisNCT01091298Shantha Biotechnics Limited20
已完成
不适用
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized ChildrenInfections, RotavirusRotavirus VaccinesNCT01177826GlaxoSmithKline643