Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

Status:	Completed
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	19 - Any
Updated:	12/27/2018
Start Date:	October 23, 2006
End Date:	February 28, 2007

A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older

The current study will provide information for the use of Boostrix concomitantly with
influenza vaccine in adults aged 19-64 years. This study will also provide safety and
immunogenicity data in a cohort of adults aged greater than or equal to 65 years.

Inclusion Criteria:

- Healthy male or female adults aged between 19 to 64 years, inclusive for the primary
cohort), or aged 65 years or older (for the exploratory cohort), at the time of
vaccination.

Exclusion Criteria:

- Administration of an influenza vaccine within six months prior to study entry

- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

- Administration of a Tdap vaccine at any time prior to study entry.

- Administration of any investigational or non-registered drug or vaccine other than the
study vaccines within 30 days preceding vaccination, or planned use during the entire
study period.

- History of diphtheria and/or tetanus and/or pertussis disease.

- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus
toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any
component of the study vaccines.

We found this trial at

sites

GSK Investigational Site

Houston, Texas 77030

from

Houston, TX