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.
Health and economic burden of recurrent respiratory tract infections (RTIs) in early childhood is considerable. A systematic review of licensed influenza and pneumococcal vaccines showed substantial efficacy in children, but the health-economic impact of such vaccines among pre-school children with recurrent RTIs is unknown. We therefore, designed a double-blind randomized controlled trial to determine the effectiveness and costs of a combined influenza and pneumococcal vaccination program among a primary care based cohort of children with recurrent episodes of RTI aged between 18 and 72 months. We will enroll 690 children over three consecutive years (2003--2005) who will be randomly allocated to receive vaccinations against influenza and pneumococcal disease, influenza alone or hepatitis B in a similar schedule. Follow up by parental diaries, tympanic temperature measurements, questionnaires and interviews is planned until May 2006. Primary outcome is number of febrile RTIs. Other outcomes include duration and severity of RTI episodes, medical consumption, safety and costs.
Schönbeck
Y
Y
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 AB Utrecht, The Netherlands. y.schonbeck@umcutrecht.nl
Sanders
E A M
EA
Hoes
A W
AW
Schilder
A G M
AG
Verheij
Th J M
TJ
Hak
E
E
D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008499:Medical Records; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011320:Primary Health Care; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000517:prevention & control; D011795:Surveys and Questionnaires; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000191:economics / Q000276:immunology
D007252:Influenza Vaccines; D022242:Pneumococcal Vaccines; D017778:Vaccines, Combined