Pneumococcal Vaccination of Otitis-prone Children
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children|
- Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children [ Time Frame: 2 years ] [ Designated as safety issue: No ]Children with an acute otitis media onset before 6 months of age, implying an 80% risk for developing recurrent acute otitis media, were allocated to vaccination with heptavalent conjugate pneumococcal vaccine or to no vaccination. The number of acute otitis media episodes before two years of age in each group were recorded.
- Nasopharyngeal carriage in young otitis-prone children [ Time Frame: 3 years ] [ Designated as safety issue: No ]The children in the vaccination study described above, had nasopharyngeal samples taken very frequently (every other month during the first year in the study, and at every suspected new episode of acute otitis media). The cultures were analyzed and compared with respect to vaccination status, risk factors, proneness to acute otitis media etc
|Study Start Date:||March 2003|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Pneumococcal vaccine
Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme).
No Intervention: Control
Half of the children were randomized to no vaccination and functioned as controls.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263210
|ENT Department, Lund University Hospital|
|Lund, Sweden, 22185|
|Principal Investigator:||Marie Gisselsson Solén, MD||ENT Department, Lund University Hospital|
|Principal Investigator:||Ann Hermansson, MD, PhD||ENT Department, Lund University Hospital|
|Principal Investigator:||Åsa Melhus, MD, PhD||Department of Clinical Bacteriology, Uppsala University Hospital|