Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

Study Overview
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Brief Summary
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The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine

Official Title
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A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

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

Intervention / Treatment
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* Biological: DTwP-HepB-Sabin IPV-Hib
* Biological: Pentavalent vaccine and Salk IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination Born at full term pregnancy (Gestational age ≥ 37 weeks) Body weight ≥ 3.2 kg at the time of screening Received one dose of hepatitis B mono-vaccine within seven days of birth Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures Written informed consent by subject's parent(s) or LAR Exclusion Criteria: Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening Known or suspected immune disorder or immunodeficient condition Receipt of immunoglobulin or blood-derived product since birth Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed. History of bleeding disorder contraindicating intramuscular injection Major congenital defects or serious chronic illness History of any neurological disorders or seizures History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.) History of allergic reactions to latex Participation in another interventional trial or received any investigational product within 30 days before to the enrollment Plan to leave the area of the study site before the end of the study period Infants who are considered unsuitable for the clinical study by the investigator

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L dose of Hexavalent<br>Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) | Biological: DTwP-HepB-Sabin IPV-Hib<br>* Intramuscular injection into the anterolateral area of the thigh<br>|
| Experimental: M dose of Hexavalent<br>Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) | Biological: DTwP-HepB-Sabin IPV-Hib<br>* Intramuscular injection into the anterolateral area of the thigh<br>|
| Experimental: H dose of Hexavalent<br>High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib). | Biological: DTwP-HepB-Sabin IPV-Hib<br>* Intramuscular injection into the anterolateral area of the thigh<br>|
| Active Comparator: Pentavalent+IPV<br>Co-administration of EupentaTM Inj and Imovax Polio | Biological: Pentavalent vaccine and Salk IPV<br>* Intramuscular injection into anterolateral area of the thigh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprotection/seroconversion/vaccine-response rate | Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components | 4 weeks after three-dose primary series | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentration (GMC) or Geometric mean titer (GMT) | GMC or GMT and their ratio of all types of antibodies | 4 weeks after three-dose primary series | 
| Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL | Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL | 4 weeks after three-dose primary series | 
| Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL | Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL | 4 weeks after three-dose primary series | 
| Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL | Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL | 4 weeks after three-dose primary series | 
| Seroconversion rate against Salk serotypes | Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype | 4 weeks after three-dose primary series | 
| Seroprotection rate against Sabin and Salk serotypes | Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype | 4 weeks after three-dose primary series |