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Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

This study has been completed.
Sponsor:
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00161122
First received: September 8, 2005
Last updated: February 13, 2008
Last verified: July 2005
History of Changes
  Purpose

The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. A target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to 22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile RTI-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.


Condition Intervention Phase
Recurrent Upper and Lower Respiratory Tract Infections (RTIs)
 Biological: trivalent inactivated influenza vaccine
Biological: combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Effectiveness and Costs of Combined Influenza and Pneumococcal Vaccination in Pre-School Children With Recurrent Respiratory Tract Infections (RTI): a General Practice-Based Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • number of febrile RTI-episodes

Secondary Outcome Measures:
  • severity and length of febrile RTI-episodes as well as medical consumption

Estimated Enrollment: 660
Study Start Date: September 2003
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Months to 72 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Age between 18-72 months
  • A history of two or more episodes of general practitioner attended RTIs

Exclusion Criteria:

  • No intention to move within 12 months to another region
  • Provision of informed consent
  • Good mastering of the Dutch language
  • Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.)
  • No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination
  • No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161122

Locations
Netherlands
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Netherlands Organisation for Scientific Research
Investigators
Principal Investigator: Eelko Hak, PhD Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00161122     History of Changes
Other Study ID Numbers: Primakid 1
Study First Received: September 8, 2005
Last Updated: February 13, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013