Status:
RECRUITING
A Phase II/III 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-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Lead Sponsor:
LG Chem
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Stage 1 (Phase 2) 1\. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
- Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
- Known history of SARS-CoV-2 infection
- Participant's mother is HepB antigen or HIV positive
- Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
- Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)
- Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
- Received immunosuppressive agents or other immune-modifying drugs
- Previous use of blood or blood-derived products
- Any history of allergy (hypersensitivity) to any of the vaccine components
- Participation in another interventional clinical trial within 4 weeks of expected first vaccination
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
1186 Patients enrolled
Trial Details
Trial ID
NCT06947499
Start Date
May 30 2025
End Date
April 1 2027
Last Update
July 3 2025
Active Locations (1)
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1
Care CT Group
Dasmariñas, Cavite, Philippines