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Sponsors and Collaborators: |
UMC Utrecht NWO |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00161122 |
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 |
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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 IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 |
Ages Eligible for Study: | 18 Months to 72 Months |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | |
Utrecht, Netherlands, 3508 GA |
Principal Investigator: | Eelko Hak, PhD | Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht |
Study ID Numbers: | Primakid 1 |
Study First Received: | September 8, 2005 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00161122 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Recurrence |
Communicable Diseases Disease Attributes Pathologic Processes Infection |