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Completed

NCT Number: NCT01263210

Pneumococcal Vaccination of Otitis-prone Children

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.

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Key information

Conditions

Recurrent Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT Department, Lund University Hospital

Lund, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Prevenar

Biological

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

  • Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Dec 20, 2010
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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