Pneumococcal Vaccination of Otitis-prone Children
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|ClinicalTrials.gov Identifier: NCT01263210|
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : December 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Acute Otitis Media||Biological: Prevenar||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2010|
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.
- Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children [ Time Frame: 2 years ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|