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

NCT00945438 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2014-01-14

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 authorisation.

Objectives:

* To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
* To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.

Conditions

Interventions

BIOLOGICAL

Influenza virus vaccine 2009-2010 formulation

0.1 mL, Intradermal

BIOLOGICAL

Influenza virus vaccine 2009-2010 formulation

0.5 mL, Intradermal

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

  • France

Study Locations

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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 NCT00945438 on ClinicalTrials.gov