Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 49
Updated:	4/21/2016
Start Date:	September 2014
End Date:	December 2014

A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

The purpose of this study is to evaluate the immunologic equivalence of three consecutive
lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess
immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit
influenza vaccine (TIVf).

The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.
Female subjects of childbearing potential were tested for pregnancy before the
administration of the vaccine and included only if using and agreeing to continue to use
contraception during the course of the study.

The total study participation time per subject is about 3 weeks.

Inclusion Criteria:

- Males or females 18 through 49 years of age.

- Subjects having provided informed consent.

- Individuals in good health

Exclusion Criteria:

- Chronic or acute illness that would interfere with the subject's safety and/or could
interfere with the evaluation of study vaccine, including known history of
anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or
receiving immunosuppressive therapy.

- Female of childbearing potential not using acceptable contraceptive methods, pregnant
or breastfeeding.

We found this trial at

sites

Rochester Clinical Research Inc.

Rochester, New York 14609

from

Rochester, NY