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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- LG Chem
- Enrollment
- 42
- Primary Endpoint
- Number of subjects with unsolicited adverse events
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of subjects with unsolicited adverse events
Time Frame: For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Unsolicited adverse events mean all the adverse events excluding the solicited adverse events that occur after the ICF is obtained until 28 days after vaccination.
Number of subjects with immediate reactions
Time Frame: For 30 minutes after the vaccination
Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.
Number of subjects with solicited adverse events
Time Frame: For 7 days after the vaccination [Day 1-8]
Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling, pruritus) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetite, diarrhea, nausea/vomiting, hypersensitivity) signs and symptoms.
Number of subjects with serious adverse events
Time Frame: For 181 days (+7 days of window period) after the vaccination [Day 1-181]
serious adverse events that occur after the ICF is obtained until 6 months after vaccination.
Secondary Outcomes
- GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)(Day 29 (+7 days window period))
- Proportions of the subjects who meet seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.(Day 29 (+7 days window period))
- Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN(Day 29 (+7 days window period))