- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161122
Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)
February 13, 2008 updated by: UMC Utrecht
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
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment
660
Phase
- Phase 4
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
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Utrecht, Netherlands, 3508 GA
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
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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 year to 6 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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number of febrile RTI-episodes
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Secondary Outcome Measures
Outcome Measure |
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severity and length of febrile RTI-episodes as well as medical consumption
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eelko Hak, PhD, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
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.
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
September 1, 2003
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
February 18, 2008
Last Update Submitted That Met QC Criteria
February 13, 2008
Last Verified
July 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Primakid 1
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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