Does the Order in Which Vaccines Are Administered Affect Pain Response?

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390130
• Other study ID #: 1000009089
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2006
• Last updated: November 10, 2013
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: November 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 6 Months

Eligibility

Inclusion Criteria:

• Healthy infant

• 2 - 6 months of age

• receiving primary DPT and PCV vaccinations

Exclusion Criteria:

• chronic illness

• immune deficiency

• immunosuppression

• a history of allergy to DPT or PCV or any of its components

• fever

• any acute illness that prevents the administration of the vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Pentacel (DPTaP+Hib)

• Prevnar (conjugated pneumococcal vaccine)

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS)		Immediately after vaccination	No