Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	September 2009
End Date:	December 2010

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Inclusion Criteria:

- Adults 18 years of age and older in good health as determined by medical history,
physical assessment and clinical judgement of the investigator and without influenza
within the past 6 months.

Exclusion Criteria:

- History of serious disease.

- History of serious reaction following administration of vaccine or hypersensitivity
to vaccine components.

- Known or suspected impairment/alteration of immune function.

- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week
before or after each study vaccination.

- Sexually active women of childbearing potential must use acceptable birth control
during the treatment phase of the study.

- For additional entry criteria, please refer to protocol.

We found this trial at

sites

Virginia Commonwealth University

Richmond, Virginia 23298

(804) 828-0100