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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- LG Chem
- Enrollment
- 1438
- Primary Endpoint
- Seroprotection/seroconservison/ vaccine-response rate
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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) 1. 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 2. 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Seroprotection/seroconservison/ vaccine-response rate
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
Secondary Outcomes
- Geometric mean concentration (GMC) or Geometric mean titer (GMT)(4 weeks after three-dose primary series)
- Immediate reactions after vaccination(30 minutes after each vaccination)
- Solicited adverse event(7 days after each vaccination)
- Unsolicited adverse event(28 days after each vaccinations)