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
  Purpose

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 Intervention Phase
Otitis Media
Pneumococcal Infections
Biological: 7-valent pneumococcal-CRM197 conjugate vaccine
Biological: 7-valent pneumococcal-OMPC conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary Outcome Measures:
  • First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

Estimated Enrollment: 3075
Study Start Date: March 1995
Estimated Study Completion Date: March 1999
  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378417

Locations
Finland
Kangasala Study Clinic
Kangasala, Finland, 36200
Nokia Study Clinic
Nokia, Finland, 37101
Itäinen and Pohjoinen Study Clinic
Tampere, Finland, 33500
Eteläinen, Keskinen, and Läntinen Study Clinic
Tampere, Finland, 33200
Kaakkoinen Study Clinic
Tampere, Finland, 33720
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Merck Sharp & Dohme Corp.
Wyeth-Lederle Vaccines
Pasteur Merieux Connaught
Investigators
Principal Investigator: Juhani Eskola, MD National Institute for Health and Welfare, Finland
Study Director: Terhi Kilpi, MD National Institute for Health and Welfare, Finland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00378417     History of Changes
Other Study ID Numbers: KTL69-0, PNC95KTL
Study First Received: September 19, 2006
Last Updated: September 19, 2006
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency

Keywords provided by National Institute for Health and Welfare, Finland:
Otitis Media
Pneumococcal Infections
Pneumococcal Vaccines
Proportional Hazards Models
Prospective Studies
Streptococcus pneumoniae
Vaccines, Conjugate

Additional relevant MeSH terms:
Otitis
Otitis Media
Pneumococcal Infections
Ear Diseases
Otorhinolaryngologic Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2014