Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

Study Overview
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Brief Summary
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The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) 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(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Detailed Description
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Stage 1 (Dose-level Finding;Phase 2) 1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2 Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3) To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Official Title
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A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active-controlled, Parallel-group, Operationally Seamless Phase 2/3 Clinical Study to Evaluate the Immunogenicity and Safety of LBVD, a Fully Liquid Hexavalent Diphtheria-Tetanus-Whole Cell Pertussis-Hepatitis B-poliomyelitis (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Given to Healthy Infants at 6-, 10-, and 14-week 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: LBVD (Hexavalent vaccine)
* Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants in stable health Male or female 6 to 8 weeks of age Signed informed consent by the infant's parent(s) or legally acceptable representative(s) Exclusion Criteria: Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration Known or suspected immunodeficiency Previous use of blood or blood-derived products Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration Any history of allergy (hypersensitivity) to any of the vaccine components Participation in another interventional clinical trial simultaneously

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: Test group 1<br>Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2 | Biological: LBVD (Hexavalent vaccine)<br>* Injection within the muscle into the front area of the thigh<br>|
| Experimental: Test group 2<br>Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2 | Biological: LBVD (Hexavalent vaccine)<br>* Injection within the muscle into the front area of the thigh<br>|
| Experimental: Test group 3<br>High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2 | Biological: LBVD (Hexavalent vaccine)<br>* Injection within the muscle into the front area of the thigh<br>|
| Active Comparator: Control group<br>Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages | Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)<br>* Injection within the muscle into the front area of the thigh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection/seroconservison/ 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 | 
| Immediate reactions after vaccination | Immediate reactions after vaccination including all the signs and symptoms that occur within 30 minutes after the vaccination will be monitored at site. It is collected as an adverse event, but is classified as an immediate reaction only if the AE occurs within 30 minutes after vaccination. | 30 minutes after each vaccination | 
| Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination | 
| Unsolicited adverse event | All unwanted or bad events after vaccination other than solicited adverse event | 28 days after each vaccinations |