Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

This study has been completed.
Netherlands Organisation for Scientific Research
Information provided by:
UMC Utrecht Identifier:
First received: September 8, 2005
Last updated: February 13, 2008
Last verified: July 2005

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:

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

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

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 identifier: NCT00161122

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
Principal Investigator: Eelko Hak, PhD Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
  More Information

Publications: 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
Respiratory Tract Diseases processed this record on April 16, 2014