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临床试验/NCT00390130
NCT00390130已完成4 期

Does the Order in Which Vaccines Are Administered Affect Pain Response? A Randomized, Double-blind, Clinical Trial of Pentacel vs. Prevnar

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS)

研究概览

简要总结

The objective of this study is to determine whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine being given first.

详细描述

Childhood vaccination is one of the most effective public health measures worldwide, with few serious adverse effects reported. However, pain on vaccination continues to be a frequent occurrence and is the most common cause of childhood iatrogenic pain. In a recent study of paediatricians in the USA, more than ninety percent reported at least one parental vaccine refusal in the past year. The most common concerns cited by parents were short-term reactions and pain from multiple injections.

One of the factors responsible for vaccination pain is the vaccine material itself. Even the same vaccine, when made by different pharmaceutical companies may produce different pain responses. Anecdotal reports from doctors and nurses indicate that Pentacel (DPTaP+Hib) is a relatively painless vaccine to administer whereas Prevnar (conjugated pneumococcal vaccine) causes significant pain on injection and severe distress to the infant being vaccinated. For this reason, many vaccinators administer Pentacel [DPT] prior to Prevnar [PCV] when providing both vaccines in one visit. However, the difference in infant pain responses has not been documented. Although it has been shown that very early pain events affect infants' later experience of pain, it has not been demonstrated that the sequence in which vaccines are administered affects pain response. This study will assess whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine (Pentacel) being given first.

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

入选标准

  • Healthy infant
  • 2 - 6 months of age
  • receiving primary DPT and PCV vaccinations

排除标准

  • chronic illness
  • immune deficiency
  • immunosuppression
  • a history of allergy to DPT or PCV or any of its components
  • any acute illness that prevents the administration of the vaccine

研究组 & 干预措施

Pentacel

Active Comparator

The subjects in this arm will be vaccinated with Pentacel

干预措施: Pentacel (DPTaP+Hib) (Drug)

Prevnar

Active Comparator

The subjects in this arm will be vaccinated with Prevnar

干预措施: Prevnar (conjugated pneumococcal vaccine) (Drug)

结局指标

主要结局

pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS)

时间窗: Immediately after vaccination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moshe Ipp

Staff Physician

The Hospital for Sick Children

研究点 (1)

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