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Pneumococcal Vaccination of Otitis-prone Children

NCT01263210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2010-12-20

No results posted yet for this study

Summary

Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small reduction in the number of AOM episodes has been noted in unselected child cohorts after vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in order to investigate whether vaccination could reduce the number of AOM episodes in very young, otitis-prone children.

Conditions

  • Recurrent Acute Otitis Media

Interventions

BIOLOGICAL

Prevenar

Sponsors & Collaborators

  • Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.

    collaborator UNKNOWN

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Marie Gisselsson Solén, MD · ENT Department, Lund University Hospital

  • Ann Hermansson, MD, PhD · ENT Department, Lund University Hospital

  • Åsa Melhus, MD, PhD · Department of Clinical Bacteriology, Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2009-06-30
Completion
2010-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263210 on ClinicalTrials.gov