Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid) - Full Text View

Sponsors and Collaborators:	UMC Utrecht NWO
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00161122

Purpose

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.

Condition	Intervention	Phase
Recurrent Upper and Lower Respiratory Tract Infections (RTIs)	Biological: trivalent inactivated influenza vaccine Biological: combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine	Phase IV

MedlinePlus related topics: Fever Flu

Drug Information available for: Influenza Vaccines Fluvirin Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

number of febrile RTI-episodes

Secondary Outcome Measures:

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

Estimated Enrollment:	660
Study Start Date:	September 2003
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Months to 72 Months
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161122

Locations

Netherlands
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA

Sponsors and Collaborators

UMC Utrecht

NWO

Investigators

Principal Investigator:

Eelko Hak, PhD

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht

More Information

Publications:

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.

Study ID Numbers:	Primakid 1
Study First Received:	September 8, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00161122
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:

Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Recurrence

Additional relevant MeSH terms:

Communicable Diseases
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009