Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

Launched by LG CHEM · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new six-in-one vaccine called LBVD, which is designed to protect healthy infants from six serious diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib). The trial aims to find out how well this vaccine works and how safe it is compared to giving separate vaccines for some of these diseases. The study will take place in two stages: the first will test different doses to find the best one, and the second will check if three batches of the vaccine are consistent in quality.

To be eligible for this study, infants need to be between 6 to 8 weeks old and in good health. Parents or guardians will need to give their consent to participate. However, infants with certain health conditions, previous vaccinations for these diseases, or recent fevers will not be able to join. If selected, participants can expect to receive the vaccine as part of their routine immunization schedule, and their health will be monitored throughout the study to ensure their safety. This trial is not yet recruiting, so no participants are enrolled at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants in stable health
• • Male or female 6 to 8 weeks of age
• • Signed informed consent by the infant's parent(s) or legally acceptable representative(s)
• Exclusion Criteria:
• • Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
• • Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration
• • Known or suspected immunodeficiency
• • Previous use of blood or blood-derived products
• • Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
• • Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
• • Any history of allergy (hypersensitivity) to any of the vaccine components
• • Participation in another interventional clinical trial simultaneously