NCT02813486

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

June 20, 2016

Last Update Submit

November 4, 2016

Conditions

TetanusDiphtheriaWhooping Cough

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine

    Up to 30 minutes post-vaccination

Study Arms (2)

GC3111 Vaccine Group

EXPERIMENTAL

Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).

Biological: Biological: GC3111 vaccine

Boostrix® Vaccine Group

ACTIVE COMPARATOR

Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).

Biological: Biological: Boostrix® vaccine

Interventions

Biological: GC3111 vaccineBIOLOGICAL

0.5mL, Intramuscular

Also known as: GC3111
GC3111 Vaccine Group
Biological: Boostrix® vaccineBIOLOGICAL

0.5mL, Intramuscular

Also known as: Boostrix®
Boostrix® Vaccine Group

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Incheon St. Mary's Hospital Catholic Univ.

Incheon, Bupyeong 6-dong, Bupyeong-gu,, 1544-9004, South Korea

Location

The Catholic Univ. of Korea Daejeon St.Mary's Hospital

Daejeon, Jung-Gu, 301-723, South Korea

Location

The Catholic Univ.of Korea Bucheon St.Mary's Hospital

Gyeonggi-do, South Korea

Location

The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital

Gyeonggi-do, South Korea

Location

The Catholic Univ.of Korea Yeouido St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

TetanusDiphtheriaWhooping Cough

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsCorynebacterium InfectionsActinomycetales InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 27, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)