Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161122
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2005-09-08
Brief Title:
Prevention of Respiratory Infections and MAnagement Among Children PRIMAKid
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None