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Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

NCT00161122 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2008-02-18

No results posted yet for this study

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

BIOLOGICAL

trivalent inactivated influenza vaccine

BIOLOGICAL

combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine

Sponsors & Collaborators

  • Netherlands Organisation for Scientific Research

    collaborator OTHER_GOV

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Eelko Hak, PhD · Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2006-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161122 on ClinicalTrials.gov