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Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

NCT00053508 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2014-01-22

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

Conditions

Interventions

BIOLOGICAL

ACAM1000

Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)

BIOLOGICAL

vaccinia virus (calf lymph) smallpox vaccine: Dryvax

group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2003-03-31
Completion
2003-09-30

Countries

  • United States

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 NCT00053508 on ClinicalTrials.gov