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Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

NCT00551031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2098

Last updated 2016-05-16

Study results available
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Summary

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data.

Primary Objective:

To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects.

Secondary Objectives:

Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.

Safety:

To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Conditions

Interventions

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)

0.1 mL, Intradermal (ID)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)

0.1 mL, Intradermal (ID)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)

0.5 mL, Intramuscular (IM)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine (High-dose)

0.5 mL, Intramuscular (IM)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)

0.5 mL, Intramuscular (IM)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00551031 on ClinicalTrials.gov