Actively 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
Led by LG Chem · Updated on 2025-07-03
1186
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants from 6 weeks to 8 weeks of age (both inclusive)
- Body weight at least 3.2 kg
- Born at full term pregnancy (37 weeks or more)
- Signed informed consent by parent(s) or legally acceptable representative(s)
You will not qualify if you...
- Known history of Hib infection, hepatitis B, diphtheria, tetanus, pertussis, or poliomyelitis
- Household contact or close exposure to confirmed cases of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliomyelitis within 30 days before study registration
- Known history of SARS-CoV-2 infection
- Participant's mother is hepatitis B antigen or HIV positive
- Fever of 38.0°C (100.4°F) or higher within 3 days before enrollment
- Vaccination with non-study vaccines within 30 days before enrollment, except pneumococcal conjugate, rotavirus, hepatitis B, or BCG vaccines
- Previous use of diphtheria, tetanus, pertussis-based combination vaccines, Hib conjugate, poliovirus, or combination vaccines
- Use of immunosuppressive agents or other immune-modifying drugs
- Previous use of blood or blood-derived products
- History of allergy to any vaccine components
- Participation in another interventional clinical trial within 4 weeks before the first vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Care CT Group
Dasmariñas, Cavite, Philippines
Actively Recruiting
Research Team
C
Clinical Study Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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