No registrations found.
ID
Source
Brief title
Health condition
recurrent upper and lower respiratory tract infections (RTI).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of febrile RTI-episodes.
Secondary outcome
Severity and length of febrile RTI-episodes as well as RTI-associated antibiotic prescriptions, medical visits, clinical laboratory diagnostic procedures, specialist referral and treatment with procedures like ventilatory tube placement or adeno-tonsillectomy, improvement of health-related quality of life, and reduced productivity loss of parents. Follow-up time varies from 7 to 22 months.
Background 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.
Study objective
Combined pneumococcal vaccination with influenza vaccinatoin reduces the occurrence of RTI in children with recurrent RTI.
Study design
N/A
Intervention
Study intervention 1:
combined heptavalent pneumococcal conjugate vaccine twice and trivalent inactivated influenza vaccine (IV) twice with one repeated IV after 1 year. (5 doses in total).
2.:
combined IV twice and placebo vaccine (saline fluid) twice) with a repeated IV after 1 year.
3.:
Control intervention: combined Hepatitis B vaccine twice and placebo vaccine (saline fluid) twice with one repeated Hepatitis B vaccination after 1 year.
Julius Center for Health Sciences and Primary Care,
P.O. Box 85500
A.G.S.C. Jansen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2538640
A.G.S.C.Jansen@umcutrecht.nl
Julius Center for Health Sciences and Primary Care,
P.O. Box 85500
A.G.S.C. Jansen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2538640
A.G.S.C.Jansen@umcutrecht.nl
Inclusion criteria
1. Age between 18-72 months;
2. A history of two or more episodes of general practitioner attended RTIs.
Exclusion criteria
1. No intention to move within 12 months to another region;
2. Provision of informed consent;
3. Good mastering of the Dutch language;
4. Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.);
5. No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination;
6. No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL186 |
| NTR-old | NTR223 |
| Other | : N/A |
| ISRCTN | ISRCTN84713819 |
Summary results
<br>
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.<br>
Vaccine. 2005 Sep 30;23(41):4906-14