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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00390130
Enrollment
120
Registered
2006-10-19
Start date
2006-07-31
Completion date
2008-07-31
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Vaccination, Pediatrics, Pain

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.

Interventions

DRUGPentacel (DPTaP+Hib)
DRUGPrevnar (conjugated pneumococcal vaccine)

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026