drugset / Trial / NCT01160237
Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FluarixTM | Vaccine | — | Intramuscular |
| Subject | PandemrixTM | Vaccine | — | Intramuscular |