NCT00161122

Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 660 (planned)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Months – 72 Months
• Healthy volunteers: —

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.

Conditions

• Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

Interventions

Type	Name	Description
BIOLOGICAL	trivalent inactivated influenza vaccine
BIOLOGICAL	combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine

Timeline

• Start date: 2003-09-01
• Completion: 2006-06-01
• First posted: 2005-09-12
• Last updated: 2008-02-18

Locations

1 site across 1 country: Netherlands