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

Launched by LG CHEM · Apr 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new vaccine called LBVD, which is designed to protect infants against several serious diseases: diphtheria, tetanus, whooping cough (pertussis), hepatitis B, polio, and a type of bacteria called Haemophilus influenzae type b (Hib). The goal is to see how well the vaccine works, how safe it is, and whether the vaccine is consistent from different batches. Healthy infants between 6 and 8 weeks old who weigh at least 3.2 kg and were born on time may be eligible to participate in the study.

If chosen to participate, infants will receive the LBVD vaccine as part of their routine immunizations, which usually happen at 6, 10, and 14 weeks of age. Parents will need to provide consent for their child to join the study. It's important to note that infants with certain health conditions or recent vaccinations may not qualify for this trial. The study is not yet recruiting participants, so parents will need to wait for further announcements about when it will begin. Overall, this trial aims to ensure that the new vaccine is safe and effective for our youngest patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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