Recurrent Upper and Lower Respiratory Tract Infections (RTIs) Clinical Trial
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
| Verified date | July 2005 |
| Source | UMC Utrecht |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Medical Ethics Review Committee (METC) |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 660 |
| Est. completion date | June 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Months to 72 Months |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| UMC Utrecht | Netherlands Organisation for Scientific Research |
Netherlands,
Schönbeck 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of febrile RTI-episodes | |||
| Secondary | severity and length of febrile RTI-episodes as well as medical consumption |