Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

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.

Timeline

Start

2003-09

Primary completion

—

Completion

2006-06

Publications

• 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.

Drugs

Indications