Recurrent Acute Otitis Media
Conditions
Keywords
Recurrent acute otitis media, Conjugate pneumococcal vaccine, Ventilation tube treatment, Nasopharyngeal flora
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 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.
Interventions
BIOLOGICALPrevenar
Sponsors
Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.
Lund University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
First episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist. \-
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasopharyngeal carriage in young otitis-prone children | 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 |
Countries
Sweden
Outcome results
None listed