Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

Green Cross Corporation

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Diphtheria

Whooping Cough

Tetanus

Treatments

Biological: Biological: GC3111 vaccine

Biological: Biological: Boostrix® vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02813486

GC3111_P1/2a

Details and patient eligibility

About

The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.

Full description

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.

To evaluate safety (solicited adverse events) of GC3111 in healthy adults.

Enrollment

220 estimated patients

Sex

All

Ages

19 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults aged between 19 and 64 years at the time of vaccination
Informed consent and assent forms have been signed and dated

Exclusion criteria

Known or suspected receipt of any Tdap vaccine
Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
Receipt of any vaccine within 30 days before receiving study vaccine
Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.