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| Name | Class |
|---|---|
| Netherlands Organisation for Scientific Research | OTHER_GOV |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trivalent inactivated influenza vaccine | Biological | |||
| combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| number of febrile RTI-episodes |
| Measure | Description | Time Frame |
|---|---|---|
| severity and length of febrile RTI-episodes as well as medical consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eelko Hak, PhD | Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | Utrecht | 3508 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16005552 | Background | Schonbeck Y, Sanders EA, Hoes AW, Schilder AG, Verheij TJ, Hak E. Rationale and design of the prevention of respiratory infections and management in children (PRIMAKid) study: a randomized controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. Vaccine. 2005 Sep 30;23(41):4906-14. doi: 10.1016/j.vaccine.2005.05.021. |
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