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Pneumococcal Vaccination of Otitis-prone Children

NCT ID: NCT01263210

Last Updated: 2010-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Recurrent Acute Otitis Media

Keywords

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Recurrent acute otitis media Conjugate pneumococcal vaccine Ventilation tube treatment Nasopharyngeal flora

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pneumococcal vaccine

Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme).

Group Type ACTIVE_COMPARATOR

Prevenar

Intervention Type BIOLOGICAL

Control

Half of the children were randomized to no vaccination and functioned as controls.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prevenar

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ENT Department, Lund University Hospital, Sweden

Principal Investigators

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Marie Gisselsson Solén, MD

Role: PRINCIPAL_INVESTIGATOR

ENT Department, Lund University Hospital

Ann Hermansson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT Department, Lund University Hospital

Åsa Melhus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Bacteriology, Uppsala University Hospital

Locations

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ENT Department, Lund University Hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 10749457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11172176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2929308 (View on PubMed)

Other Identifiers

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LU62601

Identifier Type: -

Identifier Source: org_study_id