Status:
COMPLETED
Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Netherlands Organisation for Scientific Research
Conditions:
Recurrent Upper and Lower Respiratory Tract Infections (RTIs)
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Age between 18-72 months
- A history of two or more episodes of general practitioner attended RTIs
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00161122
Start Date
September 1 2003
End Date
June 1 2006
Last Update
February 18 2008
Active Locations (1)
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1
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA