A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD 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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1 month
Healthy Volunteers: t
View:
• healthy infants from 6 weeks to 8 weeks of age (both inclusive)
• body weight ≥ 3.2 kg
• born at full term pregnancy (≥ 37 weeks)
• signed informed consent by parent(s) or legally acceptable representative(s)
Locations
Other Locations
Philippines
Care CT Group
RECRUITING
Dasmariñas
Contact Information
Primary
Clinical Study Lead
lgclinical@lgchem.com
+82-2-6987-4156
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2027-04
Participants
Target number of participants: 1186
Treatments
Experimental: Test group 1 for Stage 1
LBVD
Experimental: Test group 1 for Stage 2
LBVD Lot A
Experimental: Test group 2 for Stage 2
LBVD Lot B
Experimental: Test group 3 for Stage 2
LBVD Lot C
Active_comparator: Control group for Stage 1 and Stage 2
Co-administration of Pentavalent vaccine and Inactivated Polio vaccine
Related Therapeutic Areas
Sponsors
Leads: LG Chem