Pneumococcal Vaccination of Otitis-prone Children

Recurrent Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263210
• Other study ID #: LU62601
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: December 17, 2010
• Start date: March 2003
• Est. completion date: June 2010

Study information

• Verified date: December 2010
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Lund University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Recurrent Acute Otitis Media

Intervention

Biological:
• Prevenar

Locations

Country	Name	City	State
Sweden	ENT Department, Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Financial support was provided by the Swedish Association of Local Authorities and Regions. The vaccine was kindly supplied by Wyeth Lederle.

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Käyhty H, Karma P, Kohberger R, Siber G, Mäkelä 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. — View Citation

Harsten G, Prellner K, Heldrup J, Kalm O, Kornfält 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	3 years	No