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Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

NCT00845429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 729

Last updated 2012-12-19

Study results available
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Summary

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Conditions

  • Influenza
  • Orthomyxoviruses
  • Myxovirus Infection

Interventions

BIOLOGICAL

Influenza virus vaccine - cell based (2007-2008 Formulation)

0.5 mL, Intramuscular

BIOLOGICAL

Influenza virus vaccine - cell-based (2007-2008 Formulation)

1.0 mL, Intramuscular

BIOLOGICAL

Influenza virus vaccine (2007-2008 Formulation)

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-08-31
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 NCT00845429 on ClinicalTrials.gov