A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults

LG Chem

Status and phase: Not yet enrolling; Phase 1

Conditions: Haemophilus Influenzae Type b Infection; Poliomyelitis; Diphtheria; Hepatitis B; Pertussis; Tetanus

Treatments: Biological: DTaP-HepB-IPV-Hib vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05952596

LG-VGCL001

Details and patient eligibility

About

This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.

Enrollment: 42 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female adults aged 19 - 55 on Visit 1
• Those without clinically significant abnormalities on the screening test on Visit 1
• Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
• Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives

Exclusion criteria

• Those who participated in other studies and took investigational products/ investigational vaccines within 6 months from Visit 1
• Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
• Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
• Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Test group

Experimental group

Description:

DTaP-HepB-IPV-Hib vaccine

Treatment:

Biological: DTaP-HepB-IPV-Hib vaccine

Biological: DTaP-HepB-IPV-Hib vaccine

Control group

Active Comparator group

Description:

DTaP-HepB-IPV-Hib vaccine

Treatment:

Biological: DTaP-HepB-IPV-Hib vaccine

Biological: DTaP-HepB-IPV-Hib vaccine