Clinical trial NCT01263210: Pneumococcal Vaccination of Otitis-prone Children
Official title: Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Acute Otitis Media
Keywords: Recurrent acute otitis media
Conjugate pneumococcal vaccine
Ventilation tube treatment
Nasopharyngeal flora
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.
First posted: 2010-12-20
Enrollment: 109
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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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Primary outcomes:
measure: Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children
timeFrame: 2 years
Secondary outcomes:
measure: Nasopharyngeal carriage in young otitis-prone children
timeFrame: 3 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: ENT Department, Lund University Hospital
Study officials:
affiliation: ENT Department, Lund University Hospital
name: Marie Gisselsson Solén, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ENT Department, Lund University Hospital
name: Ann Hermansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Bacteriology, Uppsala University Hospital
name: Åsa Melhus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J. 2000 Mar;19(3):187-95. doi: 10.1097/00006454-200003000-00003.
citation: Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Kayhty H, Karma P, Kohberger R, Siber G, Makela PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8;344(6):403-9. doi: 10.1056/NEJM200102083440602.
citation: Harsten G, Prellner K, Heldrup J, Kalm O, Kornfalt R. Recurrent acute otitis media. A prospective study of children during the first three years of life. Acta Otolaryngol. 1989 Jan-Feb;107(1-2):111-9. doi: 10.3109/00016488909127487.