Status:

COMPLETED

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

Lead Sponsor:

Seqirus

Conditions:

Influenza

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Eligibility Criteria

Inclusion

  • Male or female aged 18 and older, inclusive, at the time of providing informed consent.
  • Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion

  • Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2010

Estimated Enrollment :

1313 Patients enrolled

Trial Details

Trial ID

NCT00958126

Start Date

August 1 2009

End Date

April 1 2010

Last Update

November 21 2017

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Study Site

Huntsville, Alabama, United States, 35802

2

Study Site

San Diego, California, United States, 92108

3

Study Site

Melbourne, Florida, United States, 32935

4

Study Site

Peoria, Illinois, United States, 61602