Status:
WITHDRAWN
Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
Lead Sponsor:
GlaxoSmithKline
Conditions:
Immunisation Against Streptococcus Pneumoniae
Eligibility:
All Genders
6-5 years
Brief Summary
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 author...
Detailed Description
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 appr...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- Infants aged 6 weeks and above and children.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- 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
- Subjects with contraindications according to the locally approved PI.
- Child in care.
- Previous administration of three doses of Synflorix™.
- Previous vaccination with a pneumococcal vaccine other than Synflorix™.
- Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01803425
Start Date
April 1 2013
End Date
April 1 2014
Last Update
September 9 2013
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