|- candidate number||1393|
|- NTR Number||NTR223|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||5-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Prevention of Respiratory Infections and MAnagement among Children (PRIMAKid).|
|- Scientific 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.|
|- hypothesis||Combined pneumococcal vaccination with influenza vaccinatoin reduces the occurrence of RTI in children with recurrent RTI. |
|- Healt Condition(s) or Problem(s) studied||Respiratory tract infection|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2003|
|- planned closingdate||30-jun-2005|
|- Target number of participants||660|
|- Interventions||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).
combined IV twice and placebo vaccine (saline fluid) twice) with a repeated IV after 1 year.
Control intervention: combined Hepatitis B vaccine twice and placebo vaccine (saline fluid) twice with one repeated Hepatitis B vaccination after 1 year.
|- 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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. A.G.S.C. Jansen|
|- CONTACT for SCIENTIFIC QUERIES||PhD. E. Hak|
|- Sponsor/Initiator ||Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- 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
|- 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.
|- Main changes (audit trail)|
|- RECORD||5-sep-2005 - 9-jul-2008|