Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

Phase 4

Completed

• Conditions: Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

• Registration Number: NCT00161122
• Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Status Verified: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2006-06
• Last Update Submitted: 2008-02-13
• Last Update Posted: 2008-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of febrile RTI-episodes

Secondary Outcome Measures

Name	Time	Method
severity and length of febrile RTI-episodes as well as medical consumption

Trial Locations

Locations (1)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands