Status:
COMPLETED
Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
Lead Sponsor:
Finnish Institute for Health and Welfare
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Wyeth-Lederle Vaccines
Conditions:
Otitis Media
Pneumococcal Infections
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1995
Trial Type :
INTERVENTIONAL
End Date :
March 1 1999
Estimated Enrollment :
3075 Patients enrolled
Trial Details
Trial ID
NCT00378417
Start Date
March 1 1995
End Date
March 1 1999
Last Update
September 20 2006
Active Locations (5)
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1
Kangasala Study Clinic
Kangasala, Finland, 36200
2
Nokia Study Clinic
Nokia, Finland, 37101
3
Eteläinen, Keskinen, and Läntinen Study Clinic
Tampere, Finland, 33200
4
Itäinen and Pohjoinen Study Clinic
Tampere, Finland, 33500