NCT00390130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Jul 2006

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

October 17, 2006

Last Update Submit

November 10, 2013

Conditions

Pain

Keywords

VaccinationPediatricsPain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pentacel

ACTIVE COMPARATOR

The subjects in this arm will be vaccinated with Pentacel

Drug: Pentacel (DPTaP+Hib)

Prevnar

ACTIVE COMPARATOR

The subjects in this arm will be vaccinated with Prevnar

Drug: Prevnar (conjugated pneumococcal vaccine)

Interventions

Pentacel (DPTaP+Hib)DRUG
Pentacel
Prevnar (conjugated pneumococcal vaccine)DRUG
Prevnar

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infant
  • months of age
  • receiving primary DPT and PCV vaccinations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19414694DERIVED

MeSH Terms

Conditions

Pain

Interventions

pentacelHeptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Moshe Ipp, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2007

Study Completion

July 1, 2008

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

CA(1)