Immunisation Against Streptococcus Pneumoniae Clinical Trial
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
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
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.
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Observational Model: Cohort, Time Perspective: Prospective