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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Wyeth-Lederle Vaccines
Pasteur Merieux Connaught
Information provided by:
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00378417
First received: September 19, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted

September 19, 2006
September 19, 2006
March 1995
Not Provided
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
Same as current
No Changes Posted
First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
Same as current
Not Provided
Not Provided
 
Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Otitis Media
  • Pneumococcal Infections
  • Biological: 7-valent pneumococcal-CRM197 conjugate vaccine
  • Biological: 7-valent pneumococcal-OMPC conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3075
March 1999
Not Provided

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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00378417
KTL69-0, PNC95KTL
Not Provided
Not Provided
National Institute for Health and Welfare, Finland
  • Merck Sharp & Dohme Corp.
  • Wyeth-Lederle Vaccines
  • Pasteur Merieux Connaught
Principal Investigator: Juhani Eskola, MD National Institute for Health and Welfare, Finland
Study Director: Terhi Kilpi, MD National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP