Status:
COMPLETED
Pneumococcal Vaccination of Otitis-prone Children
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.
Conditions:
Recurrent Acute Otitis Media
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief 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 nu...
Detailed Description
Ninetysix children (46 vaccinated, 50 not) with an onset of AOM before six months of age, implying a high risk for developing rAOM, were recruited between 2003 and 2007. They were closely followed wit...
Eligibility Criteria
Inclusion
- First episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist.
- \-
Exclusion
- Allergy to the vaccine, anatomical abnormality (eg cleft palate), chromosomal abnormality, immune deficiency, prematurity, prior administration of gammaglobulin or pneumococcal vaccine and a history of idiopathic thrombocytopenic purpura.
- \-
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01263210
Start Date
March 1 2003
End Date
June 1 2010
Last Update
December 20 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ENT Department, Lund University Hospital
Lund, Sweden, 22185