Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

NCT ID: NCT00161122

Last Updated: 2008-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-06-30

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.

Conditions

Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Principal Investigators

Eelko Hak, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Utrecht, , Netherlands

Countries

Netherlands

References

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. doi: 10.1016/j.vaccine.2005.05.021.

Reference Type: BACKGROUND

PMID: 16005552 (View on PubMed)

Other Identifiers

Primakid 1

Identifier Type: -

Identifier Source: org_study_id