NCT01263210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
Last Updated

December 20, 2010

Status Verified

December 1, 2010

Enrollment Period

6.3 years

First QC Date

December 17, 2010

Last Update Submit

December 17, 2010

Conditions

Recurrent Acute Otitis Media

Keywords

Recurrent acute otitis mediaConjugate pneumococcal vaccineVentilation tube treatmentNasopharyngeal flora

Outcome Measures

Primary Outcomes (1)

  • Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children

    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.

    2 years

Secondary Outcomes (1)

  • Nasopharyngeal carriage in young otitis-prone children

    3 years

Study Arms (2)

Pneumococcal vaccine

ACTIVE COMPARATOR

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

Biological: Prevenar

Control

NO INTERVENTION

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

Interventions

PrevenarBIOLOGICAL
Pneumococcal vaccine

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Department, Lund University Hospital

Lund, 22185, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 10749457BACKGROUND

  • 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.

    PMID: 11172176BACKGROUND

  • 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.

    PMID: 2929308BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 20, 2010

Study Start

March 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

December 20, 2010

Record last verified: 2010-12

Locations

SE(1)