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

A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active-controlled, Parallel-group, Operationally Seamless Phase 2/3 Clinical Study to Evaluate the Immunogenicity and Safety of LBVD, a Fully Liquid Hexavalent Diphtheria-Tetanus-Whole Cell Pertussis-Hepatitis B-poliomyelitis (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Given to Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type B Infection
• Intervention / Treatment: Biological: LBVD (Hexavalent vaccine); Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Detailed Description

Stage 1 (Dose-level Finding;Phase 2)

1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2

Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3)

1. To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
2. To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

• Study Type: Interventional
• Enrollment (Anticipated): 1438
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Study Lead; Phone Number: +82-2-3777-1114; Email: lgclinical@lgchem.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group 1; 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); Injection within the muscle into the front area of the thigh
Experimental: Test group 2; 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); Injection within the muscle into the front area of the thigh
Experimental: Test group 3; 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); Injection within the muscle into the front area of the thigh
Active Comparator: Control group; Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages	Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains); Injection within the muscle into the front area of the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean concentration (GMC) or Geometric mean titer (GMT)	GMC or GMT and their ratio of all types of antibodies	4 weeks after three-dose primary series
Solicited adverse event	Expected local or systemic side effects after vaccination	7 days after each vaccination
Unsolicited adverse event	All unwanted or bad events after vaccination other than solicited adverse event	28 days after each vaccinations
Immediate reactions after vaccination	Immediate reactions after vaccination including all the signs and symptoms that occur within 30 minutes after the vaccination will be monitored at site. It is collected as an adverse event, but is classified as an immediate reaction only if the AE occurs within 30 minutes after vaccination.	30 minutes after each vaccination

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Edison Alberto, MD, Health Index Multispecialty Clinic; Principal Investigator: Josefina Carlos, MD, UERM Memorial Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Orthomyxoviridae Infections; Clostridium Infections; Corynebacterium Infections; Myelitis; Pasteurellaceae Infections; Hepatitis B; Whooping Cough; Hepatitis; Influenza, Human; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LG-VDCL003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No