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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Pentacel (DPTaP+Hib)
* Drug: Prevnar (conjugated pneumococcal vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pentacel<br>The subjects in this arm will be vaccinated with Pentacel | Drug: Pentacel (DPTaP+Hib)<br> <br> |
| Active Comparator: Prevnar<br>The subjects in this arm will be vaccinated with Prevnar | Drug: Prevnar (conjugated pneumococcal vaccine)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Pediatrics, Pain