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

NCT ID: NCT00390130

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-07-31

Brief 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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pentacel

The subjects in this arm will be vaccinated with Pentacel

Group Type: ACTIVE_COMPARATOR

Pentacel (DPTaP+Hib)

Intervention Type: DRUG

Prevnar

The subjects in this arm will be vaccinated with Prevnar

Group Type: ACTIVE_COMPARATOR

Prevnar (conjugated pneumococcal vaccine)

Intervention Type: DRUG

Interventions

Pentacel (DPTaP+Hib)

Intervention Type: DRUG

Prevnar (conjugated pneumococcal vaccine)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Moshe Ipp

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moshe Ipp, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

Ipp M, Parkin PC, Lear N, Goldbach M, Taddio A. Order of vaccine injection and infant pain response. Arch Pediatr Adolesc Med. 2009 May;163(5):469-72. doi: 10.1001/archpediatrics.2009.35.

Reference Type: DERIVED

PMID: 19414694 (View on PubMed)

Other Identifiers

1000009089

Identifier Type: -

Identifier Source: org_study_id