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Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

NCT01631110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2013-12-20

Study results available
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Summary

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions

Interventions

BIOLOGICAL

Inflexal V

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Michael Seiberling, MD · Covance Clinical Research Unit AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01631110 on ClinicalTrials.gov