Clinical Trials Directory

Trials / Completed

CompletedNCT01263210

Pneumococcal Vaccination of Otitis-prone Children

Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
109 (actual)
Sponsor
Lund University Hospital · Academic / Other
Sex
All
Age
6 Months
Healthy volunteers
Not accepted

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.

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 with clinical visits and nasopharyngeal cultures until the age of two years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPrevenar

Timeline

Start date
2003-03-01
Primary completion
2009-06-01
Completion
2010-06-01
First posted
2010-12-20
Last updated
2010-12-20

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01263210. Inclusion in this directory is not an endorsement.