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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02813486

Enrollment

220

Registered

2016-06-27

Start date

2016-06-30

Completion date

2016-11-30

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Tetanus, Whooping Cough

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALBiological: GC3111 vaccine

0.5mL, Intramuscular

BIOLOGICALBiological: Boostrix® vaccine

0.5mL, Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine	Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens	28 days after Vaccination
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens	28 days after Vaccination
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis	Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Secondary

Measure	Time frame
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine	Up to 30 minutes post-vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026