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Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix™ cohort | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorix™ data collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs) | During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall | |
| Occurrence of unsolicited AEs | During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall | |
| Occurrence of Serious Adverse Events (SAEs) | 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 |
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Inclusion Criteria:
Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.
Exclusion Criteria:
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Healthy Sri Lankan infants aged 6 weeks and above and children
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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