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Pneumococcal Vaccination of Otitis-prone Children

Primary Purpose

Recurrent Acute Otitis Media

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Prevenar

About this trial

This is an interventional prevention trial for Recurrent Acute Otitis Media focused on measuring Recurrent acute otitis media, Conjugate pneumococcal vaccine, Ventilation tube treatment, Nasopharyngeal flora

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ENT Department, Lund University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pneumococcal vaccine

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nasopharyngeal carriage in young otitis-prone children

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

Full Information

NCT ID

NCT01263210

First Posted

December 17, 2010

Last Updated

December 17, 2010

Sponsor

Lund University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01263210

Brief Title

Pneumococcal Vaccination of Otitis-prone Children

Official Title

Conjugate Pneumococcal Vaccination - a Randomized Study in Young Otitis-prone Children

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Lund University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Acute Otitis Media

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pneumococcal vaccine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Prevenar

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Nasopharyngeal carriage in young otitis-prone children

Description

Time Frame

3 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Gisselsson Solén, MD

Organizational Affiliation

ENT Department, Lund University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ann Hermansson, MD, PhD

Organizational Affiliation

ENT Department, Lund University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Åsa Melhus, MD, PhD

Organizational Affiliation

Department of Clinical Bacteriology, Uppsala University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

ENT Department, Lund University Hospital

City

Lund

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

10749457

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.

Results Reference

background

PubMed Identifier

11172176

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.

Results Reference

background

PubMed Identifier

2929308

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.

Results Reference

background

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Pneumococcal Vaccination of Otitis-prone Children

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