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

NCT05457946 | Unknown Phase 2

• 1 other identifier: LG-VDCL003
• Study Type: interventional
• Target: 1,438
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine 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 and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection

Outcome Measures

Primary Outcomes (1)

• Seroprotection/seroconservison/ vaccine-response rate

  Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

  4 weeks after three-dose primary series

Secondary Outcomes (4)

• Geometric mean concentration (GMC) or Geometric mean titer (GMT)

  4 weeks after three-dose primary series

• Immediate reactions after vaccination

  30 minutes after each vaccination

• Solicited adverse event

  7 days after each vaccination

• Unsolicited adverse event

  28 days after each vaccinations

Study Arms (4)

Test group 1

EXPERIMENTAL

Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2

Biological: LBVD (Hexavalent vaccine)

Test group 2

EXPERIMENTAL

Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2

Biological: LBVD (Hexavalent vaccine)

Test group 3

EXPERIMENTAL

High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2

Biological: LBVD (Hexavalent vaccine)

Control group

ACTIVE COMPARATOR

Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages

Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Interventions

LBVD (Hexavalent vaccine) BIOLOGICAL

Injection within the muscle into the front area of the thigh

Test group 1; Test group 2; Test group 3

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) BIOLOGICAL

Injection within the muscle into the front area of the thigh

Control group

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Haemophilus Infections

Interventions

Vaccines, Combined; Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures; Vaccines, Inactivated; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Edison Alberto, MD

  Health Index Multispecialty Clinic

  PRINCIPAL INVESTIGATOR

• Josefina Carlos, MD

  UERM Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Lead

CONTACT

+82-2-3777-1114; lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: April 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03