Pneumococcal Vaccination of Otitis-prone Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Recurrent Acute Otitis Media

Intervention / Treatment
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* Biological: Prevenar


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pneumococcal vaccine<br>Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme). | Biological: Prevenar<br> <br> |
| No Intervention: Control<br>Half of the children were randomized to no vaccination and functioned as controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent acute otitis media, Conjugate pneumococcal vaccine, Ventilation tube treatment, Nasopharyngeal flora