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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Biological: DTaP-HepB-IPV-Hib vaccine
* Biological: DTaP-HepB-IPV-Hib vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: active-controlled model
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>DTaP-HepB-IPV-Hib vaccine | Biological: DTaP-HepB-IPV-Hib vaccine<br>* Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)<br>|
| Active Comparator: Control group<br>DTaP-HepB-IPV-Hib vaccine | Biological: DTaP-HepB-IPV-Hib vaccine<br>* Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with immediate reactions | Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination. | For 30 minutes after the vaccination | 
| Number of subjects with solicited adverse events | 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. | For 7 days after the vaccination [Day 1-8] | 
| Number of subjects with unsolicited adverse events | 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. | For 28 days (+7 days of window period) after the vaccination [Day 1-29] | 
| Number of subjects with serious adverse events | serious adverse events that occur after the ICF is obtained until 6 months after vaccination. | For 181 days (+7 days of window period) after the vaccination [Day 1-181] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b) | Day 29 (+7 days window period) | 
| Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN | ①If the antibody concentration is < 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration is ≥ 4 X LLOQ 29 days after the administration of the investigational vaccine ②If the antibody concentration is ≥ 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration 29 days after the administration of the investigational vaccine is ≥ the antibody concentration before the administration | Day 29 (+7 days window period) | 
| GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29) | Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b | Day 29 (+7 days window period) |