Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
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|ClinicalTrials.gov Identifier: NCT00378417|
Recruitment Status : Completed
First Posted : September 20, 2006
Last Update Posted : September 20, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media Pneumococcal Infections||Biological: 7-valent pneumococcal-CRM197 conjugate vaccine Biological: 7-valent pneumococcal-OMPC conjugate vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3075 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||March 1995|
|Study Completion Date :||March 1999|
- Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
- First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378417
|Kangasala Study Clinic|
|Kangasala, Finland, 36200|
|Nokia Study Clinic|
|Nokia, Finland, 37101|
|Eteläinen, Keskinen, and Läntinen Study Clinic|
|Tampere, Finland, 33200|
|Itäinen and Pohjoinen Study Clinic|
|Tampere, Finland, 33500|
|Kaakkoinen Study Clinic|
|Tampere, Finland, 33720|
|Principal Investigator:||Juhani Eskola, MD||National Institute for Health and Welfare, Finland|
|Study Director:||Terhi Kilpi, MD||National Institute for Health and Welfare, Finland|