Combined pneumococcal vaccination with influenza vaccinatoin reduces the occurrence of RTI in children with recurrent RTI.
ID
Bron
Verkorte titel
Aandoening
recurrent upper and lower respiratory tract infections (RTI).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of febrile RTI-episodes.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Combined pneumococcal vaccination with influenza vaccinatoin reduces the occurrence of RTI in children with recurrent RTI.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age between 18-72 months;
2. A history of two or more episodes of general practitioner attended RTIs.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL186 |
| NTR-old | NTR223 |
| Ander register | : N/A |
| ISRCTN | ISRCTN84713819 |
Samenvatting resultaten
<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