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

NCT01160237 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-10-20

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

PandemrixTM

One dose intramuscular injection

BIOLOGICAL

FluarixTM/ Influsplit SSW® 2010/2011

One dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT01160237 on ClinicalTrials.gov