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Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

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ClinicalTrials.gov Identifier: NCT00161122
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 18, 2008
Netherlands Organisation for Scientific Research
Information provided by:
UMC Utrecht

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2003
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. number of febrile RTI-episodes

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 72 Months   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00161122     History of Changes
Other Study ID Numbers: Primakid 1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: July 2005

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs