2,258
Participants
Start Date
June 30, 2011
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
Data collection (Retrospective)
For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to \< 6 years) or since birth (for subjects aged \< 1 year) will be recorded in the electronic case report form.
Data collection (Prospective)
For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.
GSK Investigational Site, Ljubljana
GSK Investigational Site, Ljubljana
GSK Investigational Site, Maribor
GSK Investigational Site, Ptuj
GSK Investigational Site, Ruše
GSK Investigational Site, Tallinn
GSK Investigational Site, Craiova
GSK Investigational Site, Brasov
GSK Investigational Site, Bacau
GSK Investigational Site, Galati
GSK Investigational Site, Vilnius
GSK Investigational Site, Vilnius
GSK Investigational Site, Vilnius
GSK Investigational Site, Bydgoszcz
GSK Investigational Site, Dębica
GSK Investigational Site, Katowice
GSK Investigational Site, Kielce
GSK Investigational Site, Siemianowice Śląskie
GSK Investigational Site, Tarnów
GSK Investigational Site, Warsaw
GSK Investigational Site, Wejherowo
GSK Investigational Site, Wola
GSK Investigational Site, Łęczna
GSK Investigational Site, Bucharest
GSK Investigational Site, Maribor
Lead Sponsor
GlaxoSmithKline
INDUSTRY