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

The Hospital for Sick Children

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Pentacel (DPTaP+Hib); Drug: Prevnar (conjugated pneumococcal vaccine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00390130

1000009089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Pentacel

Active Comparator group

Description:

The subjects in this arm will be vaccinated with Pentacel

Treatment:

Drug: Pentacel (DPTaP+Hib)

Prevnar

Active Comparator group

Description:

The subjects in this arm will be vaccinated with Prevnar

Treatment:

Drug: Prevnar (conjugated pneumococcal vaccine)