Hepatitis B Clinical Trial
Official title:
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
Verified date | March 2023 |
Source | LG Chem |
Contact | Study Lead |
Phone | +82-2-3777-1114 |
lgclinical[@]lgchem.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Not yet recruiting |
Enrollment | 1438 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 8 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LG Chem |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination | |
Secondary | Unsolicited adverse event | All unwanted or bad events after vaccination other than solicited adverse event | 28 days after each vaccinations |
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