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Trial record 78 of 452 for:    OTITIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00378417
Recruitment Status : Completed
First Posted : September 20, 2006
Last Update Posted : September 20, 2006
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Wyeth-Lederle Vaccines
Pasteur Merieux Connaught
Information provided by:
National Institute for Health and Welfare, Finland

Tracking Information
First Submitted Date  ICMJE September 19, 2006
First Posted Date  ICMJE September 20, 2006
Last Update Posted Date September 20, 2006
Study Start Date  ICMJE March 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Otitis Media
  • Pneumococcal Infections
Intervention  ICMJE
  • Biological: 7-valent pneumococcal-CRM197 conjugate vaccine
  • Biological: 7-valent pneumococcal-OMPC conjugate vaccine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 19, 2006)
3075
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 1999
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00378417
Other Study ID Numbers  ICMJE KTL69-0
PNC95KTL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute for Health and Welfare, Finland
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Wyeth-Lederle Vaccines
  • Pasteur Merieux Connaught
Investigators  ICMJE
Principal Investigator: Juhani Eskola, MD National Institute for Health and Welfare, Finland
Study Director: Terhi Kilpi, MD National Institute for Health and Welfare, Finland
PRS Account National Institute for Health and Welfare, Finland
Verification Date September 2006

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