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A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

NCT01089660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2014-01-14

No results posted yet for this study

Summary

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Conditions

Interventions

BIOLOGICAL

Swine A/H1N1 influenza vaccine (split virion, inactivated)

0.3 mL, Intramuscular (IM)

BIOLOGICAL

Swine A/H1N1 influenza vaccine (split virion, inactivated)

0.5 mL, Intramuscular (IM)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • France

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 NCT01089660 on ClinicalTrials.gov