Back to resultsStudy to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LBVD (Hexavalent vaccine)
Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Test group 1
Test group 2
Test group 3
Control group
Arm Description
Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2
Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2
High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2
Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages
Outcomes
Primary Outcome Measures
Seroprotection/seroconservison/ vaccine-response rate
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
Secondary Outcome Measures
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
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.
Solicited adverse event
Expected local or systemic side effects after vaccination
Unsolicited adverse event
All unwanted or bad events after vaccination other than solicited adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05457946
Brief Title
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1438 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group 1
Arm Type
Experimental
Arm Description
Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2
Arm Title
Test group 2
Arm Type
Experimental
Arm Description
Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2
Arm Title
Test group 3
Arm Type
Experimental
Arm Description
High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages
Intervention Type
Biological
Intervention Name(s)
LBVD (Hexavalent vaccine)
Intervention Description
Injection within the muscle into the front area of the thigh
Intervention Type
Biological
Intervention Name(s)
Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
Intervention Description
Injection within the muscle into the front area of the thigh
Primary Outcome Measure Information:
Title
Seroprotection/seroconservison/ vaccine-response rate
Description
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
Time Frame
4 weeks after three-dose primary series
Secondary Outcome Measure Information:
Title
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Description
GMC or GMT and their ratio of all types of antibodies
Time Frame
4 weeks after three-dose primary series
Title
Immediate reactions after vaccination
Description
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.
Time Frame
30 minutes after each vaccination
Title
Solicited adverse event
Description
Expected local or systemic side effects after vaccination
Time Frame
7 days after each vaccination
Title
Unsolicited adverse event
Description
All unwanted or bad events after vaccination other than solicited adverse event
Time Frame
28 days after each vaccinations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Lead
Phone
+82-2-3777-1114
Email
lgclinical@lgchem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edison Alberto, MD
Organizational Affiliation
Health Index Multispecialty Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josefina Carlos, MD
Organizational Affiliation
UERM Memorial Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
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