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Study of Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation

NCT00946179 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-01-17

No results posted yet for this study

Summary

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization.

Objectives:

* To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older.
* To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.

Conditions

Interventions

BIOLOGICAL

Influenza virus (split virion, inactivated) vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30
Completion
2009-07-31

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 NCT00946179 on ClinicalTrials.gov