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Prevention of Respiratory Infections and MAnagement among Children (PRIMAKid).


- candidate number1393
- NTR NumberNTR223
- ISRCTNISRCTN84713819
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsN/A 
- Public TitlePrevention of Respiratory Infections and MAnagement among Children (PRIMAKid).
- Scientific TitleEffectiveness 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.
- ACRONYMPRIMAKid
- hypothesisCombined pneumococcal vaccination with influenza vaccinatoin reduces the occurrence of RTI in children with recurrent RTI.
- Healt Condition(s) or Problem(s) studiedRespiratory tract infection
- Inclusion criteria1. Age between 18-72 months;
2. A history of two or more episodes of general practitioner attended RTIs.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2003
- planned closingdate30-jun-2005
- Target number of participants660
- InterventionsStudy 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.
- Primary outcomeNumber of febrile RTI-episodes.
- Secondary outcomeSeverity 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. A.G.S.C. Jansen
- CONTACT for SCIENTIFIC QUERIESPhD. E. Hak
- Sponsor/Initiator Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsSchonbeck 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 summaryThe 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)
- RECORD5-sep-2005 - 9-jul-2008


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