Pneumococcal Vaccination of Otitis-prone Children

Recurrent Acute Otitis Media Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Recurrent Acute Otitis Media

• NCT number: NCT01263210
• Study type: Interventional
• Source: Lund University Hospital
• Status: Completed
• Phase: N/A
• Start date: March 2003
• Completion date: June 2010