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Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka

NCT01803425 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2013-09-09

No results posted yet for this study

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 authority.

Conditions

  • Immunisation Against Streptococcus Pneumoniae

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Weeks
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01803425 on ClinicalTrials.gov