MedTrace Logo

Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

NCT00819013 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2012-01-19

Study results available
· View outcomes & findings →

Summary

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

Conditions

Interventions

BIOLOGICAL

Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular

BIOLOGICAL

Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular

BIOLOGICAL

Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM FLU-A low dose, Intramuscular

BIOLOGICAL

Saline placebo

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00819013 on ClinicalTrials.gov