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

September 19, 2006 updated by: Finnish Institute for Health and Welfare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

3075

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kangasala, Finland, 36200
        • Kangasala Study Clinic
      • Nokia, Finland, 37101
        • Nokia Study Clinic
      • Tampere, Finland, 33200
        • Eteläinen, Keskinen, and Läntinen Study Clinic
      • Tampere, Finland, 33500
        • Itäinen and Pohjoinen Study Clinic
      • Tampere, Finland, 33720
        • Kaakkoinen Study Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary Outcome Measures

Outcome Measure
First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Merck Sharp & Dohme LLC
Wyeth-Lederle Vaccines
Pasteur Merieux Connaught

Investigators

  • Principal Investigator: Juhani Eskola, MD, Finnish Institute for Health and Welfare
  • Study Director: Terhi Kilpi, MD, Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Study Completion

March 1, 1999

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2006

Last Update Submitted That Met QC Criteria

September 19, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTL69-0
  • PNC95KTL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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