drugset / Trial / NCT01160237

Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM

NCT01160237 ↗

Phase 3 Terminated 7 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control. This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.

Timeline

Start
2010-08
Primary completion
2011-02
Completion
2011-02

Outcome

Outcome not reported

Stopped: “The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.”

Drugs

EvaluationDrugModalityDoseRoute
Subject FluarixTM Vaccine — Intramuscular
Subject PandemrixTM Vaccine — Intramuscular

Indications