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Pneumococcal Vaccination of Otitis-prone Children

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ClinicalTrials.gov Identifier: NCT01263210
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : December 20, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Recurrent Acute Otitis Media Biological: Prevenar

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children
Study Start Date : March 2003
Primary Completion Date : June 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).
Biological: Prevenar
No Intervention: Control
Half of the children were randomized to no vaccination and functioned as controls.

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263210

ENT Department, Lund University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
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
More Information

Responsible Party: Marie Gisselsson Solén, ENT Department, Lund University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01263210     History of Changes
Other Study ID Numbers: LU62601
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Keywords provided by Lund University Hospital:
Recurrent acute otitis media
Conjugate pneumococcal vaccine
Ventilation tube treatment
Nasopharyngeal flora

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs