Pneumococcal Vaccination of Otitis-prone Children

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Acute Otitis Media
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • ENT Department, Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: First episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• 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.
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 17, 2010
• First Posted (Estimate): December 20, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2010
• Last Update Submitted That Met QC Criteria: December 17, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Recurrent acute otitis media; Conjugate pneumococcal vaccine; Ventilation tube treatment; Nasopharyngeal flora
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: LU62601