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Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

NCT00772109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4292

Last updated 2016-04-14

Study results available
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Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

* To demonstrate lot consistency of the Fluzone ID manufacturing process.
* To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

* To describe the safety profile of subjects who receive of Fluzone ID.

Conditions

  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection

Interventions

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-07-31

Countries

  • United States
  • Puerto Rico

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 NCT00772109 on ClinicalTrials.gov