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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Moshe Ipp, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00390130
First received: October 17, 2006
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Pentacel (DPTaP+Hib)
Drug: Prevnar (conjugated pneumococcal vaccine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does the Order in Which Vaccines Are Administered Affect Pain Response? A Randomized, Double-blind, Clinical Trial of Pentacel vs. Prevnar

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) [ Time Frame: Immediately after vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pentacel
The subjects in this arm will be vaccinated with Pentacel
Drug: Pentacel (DPTaP+Hib)
Active Comparator: Prevnar
The subjects in this arm will be vaccinated with Prevnar
Drug: Prevnar (conjugated pneumococcal vaccine)

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390130

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Moshe Ipp, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moshe Ipp, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00390130     History of Changes
Other Study ID Numbers: 1000009089
Study First Received: October 17, 2006
Last Updated: November 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Vaccination
Pediatrics
Pain

ClinicalTrials.gov processed this record on July 31, 2014