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Pneumococcal Vaccination of Otitis-prone Children

This study has been completed.
Sponsor:
Collaborator:
Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01263210
First received: December 17, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 17, 2010
December 17, 2010
March 2003
June 2009   (final data collection date for primary outcome measure)
Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Nasopharyngeal carriage in young otitis-prone children [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Pneumococcal Vaccination of Otitis-prone Children
Conjugate Pneumococcal Vaccination - a Randomized Study in Young 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Recurrent Acute Otitis Media
Biological: Prevenar
  • Active Comparator: Pneumococcal vaccine
    Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme).
    Intervention: Biological: Prevenar
  • No Intervention: Control
    Half of the children were randomized to no vaccination and functioned as controls.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
June 2010
June 2009   (final data collection date for primary outcome measure)

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.

-

Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01263210
LU62601
Yes
Marie Gisselsson Solén, ENT Department, Lund University Hospital, Sweden
Lund University Hospital
Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.
Principal Investigator: Marie Gisselsson Solén, MD ENT Department, Lund University Hospital
Principal Investigator: Ann Hermansson, MD, PhD ENT Department, Lund University Hospital
Principal Investigator: Åsa Melhus, MD, PhD Department of Clinical Bacteriology, Uppsala University Hospital
Lund University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP