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Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

NCT01011049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2016-04-14

Study results available
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Summary

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

* To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

* To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Conditions

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

0.5 mL, Intramuscular

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.5 mL, Intramuscular

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2010-10-31

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 NCT01011049 on ClinicalTrials.gov