Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
|Immunisation Against Streptococcus Pneumoniae||Other: Synflorix™ data collection|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post-marketing Surveillance (PMS) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Conjugate Vaccine (Synflorix™) When Administered to Healthy Infants and Children According to the Prescribing Information in Sri Lanka|
- Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs) [ Time Frame: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall ]
- Occurrence of unsolicited AEs [ Time Frame: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Only those subjects to whom Synflorix™ will be administered as per normal clinical practice, according to the locally approved PI, will be included in the study.
Other: Synflorix™ data collection
Safety monitoring and evaluation: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. Recording of SAEs throughout the study period for each subject.
The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803425
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|