Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Study Overview
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Brief Summary
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This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine). The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated. The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.

Official Title
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Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines

Conditions
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Otitis Media, Pneumococcal Infections

Intervention / Treatment
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* Biological: 7-valent pneumococcal-CRM197 conjugate vaccine
* Biological: 7-valent pneumococcal-OMPC conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination family living permanently in Tampere, Kangasala or Nokia at least one of the parents/guardians is able to communicate fluently in Finnish written informed consent obtained from a parent/guardian prior to enrollment in the study Exclusion Criteria: hypersensitivity to any of the components of the vaccines used in the study, known or suspected impairment of immunologic function, history of invasive pneumococcal disease, prior vaccination with any pneumococcal vaccine, prior vaccination with hepatitis B vaccine, contraindications to routine childhood immunizations any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 7-valent pneumococcal-CRM197 conjugate vaccine|nan|
|Biological: 7-valent pneumococcal-OMPC conjugate vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate