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| Name | Class |
|---|---|
| Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumococcal vaccine | Active Comparator | Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme). |
|
| Control | No Intervention | Half of the children were randomized to no vaccination and functioned as controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Nasopharyngeal carriage in young otitis-prone children | 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 |
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Inclusion Criteria: First episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist.
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Exclusion Criteria: 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.
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| Name | Affiliation | Role |
|---|---|---|
| Marie Gisselsson Solén, MD | ENT Department, Lund University Hospital | Principal Investigator |
| Ann Hermansson, MD, PhD | ENT Department, Lund University Hospital | Principal Investigator |
| Ã…sa Melhus, MD, PhD | Department of Clinical Bacteriology, Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT Department, Lund University Hospital | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10749457 | Background | Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J. 2000 Mar;19(3):187-95. doi: 10.1097/00006454-200003000-00003. | |
| 11172176 |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
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| 3 years |
| Background |
| Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Kayhty H, Karma P, Kohberger R, Siber G, Makela PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8;344(6):403-9. doi: 10.1056/NEJM200102083440602. |
| 2929308 | Background | Harsten G, Prellner K, Heldrup J, Kalm O, Kornfalt R. Recurrent acute otitis media. A prospective study of children during the first three years of life. Acta Otolaryngol. 1989 Jan-Feb;107(1-2):111-9. doi: 10.3109/00016488909127487. |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |