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

NCT06947499 | Recruiting Phase 2 DMC

• 1 other identifier: LG-VDCL004
• Study Type: interventional
• Target: 1,186
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

vaccination

Outcome Measures

Primary Outcomes (2)

• Seroprotection/seroconversion rate

  proportion of participants achieving pre-defined immune response to each antigen

  4 weeks after a three-dose primary series

• Geometric mean concentration (GMC) for pertussis

  GMC for pertussis antigen

  4 weeks after a three-dose primary series

Secondary Outcomes (5)

• Geometric mean titer (GMT) or GMC

  4 weeks after the three-dose primary series

• Seroprotection/seroconversion rate

  4 weeks after the three-dose primary series

• Immediate reactions after vaccination

  30 minutes after each vaccination

• Solicited adverse event

  within 7 days after each vaccination

• Unsolicited adverse event

  4 weeks after the three-dose primary series

Study Arms (5)

Test group 1 for Stage 1

EXPERIMENTAL

LBVD

Biological: LBVD

Test group 1 for Stage 2

EXPERIMENTAL

LBVD Lot A

Biological: LBVD

Test group 2 for Stage 2

EXPERIMENTAL

LBVD Lot B

Biological: LBVD

Test group 3 for Stage 2

EXPERIMENTAL

LBVD Lot C

Biological: LBVD

Control group for Stage 1 and Stage 2

ACTIVE COMPARATOR

Co-administration of Pentavalent vaccine and Inactivated Polio vaccine

Biological: Pentavalent vaccine and Inactivated Polio vaccine

Interventions

LBVD BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

Test group 1 for Stage 1; Test group 1 for Stage 2; Test group 2 for Stage 2; Test group 3 for Stage 2

Pentavalent vaccine and Inactivated Polio vaccine BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

Control group for Stage 1 and Stage 2

Eligibility Criteria

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

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
• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Care CT Group

Dasmariñas, Cavite, Philippines

RECRUITING

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

Central Study Contacts

Clinical Study Lead

CONTACT

+82-2-6987-4156; 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: April 20, 2025
• First Posted: April 27, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

PH (1)