A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

GC Biopharma

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Tetanus-diphtheria-acellular Pertussis (Tdap)

Treatments: Biological: GC3111B; Biological: Boostrix®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06997627

GC3111B_Tdap_P1201

Details and patient eligibility

About

This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults aged 19 to 64 years old as of the date of written consent.
• Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.

Exclusion criteria

• Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.
• Individuals with a history of Tdap vaccination prior to administration of the investigational product.
• Pregnant and breastfeeding women.
• Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

GC3111B

Experimental group

Description:

Participants randomized to receive a single dose of GC3111B vaccine.

Treatment:

Biological: GC3111B

Boostrix®

Active Comparator group

Description:

Participants randomized to receive a single dose of Boostrix® vaccine.

Treatment:

Biological: Boostrix®