RecruitingDiphtheriaTetanusPertussis
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
Eligible age
0–0 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
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About this study
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
Sponsor: LG Chem
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT06947499 · last updated 2025-07-03