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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05457946
• Other study ID #: LG-VDCL003
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: LG Chem
• Contact: Study Lead
• Phone: +82-2-3777-1114
• Email: lgclinical[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1438
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Haemophilus Influenzae Type B Infection
• Hepatitis
• Hepatitis B
• Influenza, Human
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• LBVD (Hexavalent vaccine)
Injection within the muscle into the front area of the thigh
• Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
Injection within the muscle into the front area of the thigh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Solicited adverse event	Expected local or systemic side effects after vaccination	7 days after each vaccination
Secondary	Unsolicited adverse event	All unwanted or bad events after vaccination other than solicited adverse event	28 days after each vaccinations