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

A Single-center, Randomized, Active-controlled, Parallel-group, Double-blind, Phase I Clinical Trial to Evaluate Safety and Immunogenicity of Hexavalent Vaccine (APV006) in Healthy Adults

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.

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