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Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

NCT00664417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2012-04-17

No results posted yet for this study

Summary

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

Conditions

Interventions

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 1

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 2

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 3

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 4

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 5

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 6

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Comparator 1

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Comparator 2

BIOLOGICAL

Physiological saline

0.5 mL, IM, 2 injections

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Sanofi Pasteur, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-09-30
Completion
2010-08-31

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 NCT00664417 on ClinicalTrials.gov