Clinical trial

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

Name

LG-VDCL003

Description

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)

Trial arms

Trial start

2023-04-01

Estimated PCD

2025-09-30

Trial end

2025-09-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

LBVD (Hexavalent vaccine)

Injection within the muscle into the front area of the thigh

Arms:

Test group 1, Test group 2, Test group 3

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Injection within the muscle into the front area of the thigh

Arms:

Control group

Size

1438

Primary endpoint

Seroprotection/seroconservison/ vaccine-response rate

4 weeks after three-dose primary series

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1438, 'type': 'ESTIMATED'}}

Updated at

2023-03-10

1 organization

2 products

6 indications

Organization

LG Chem

Product

LBVD

Indication

Diphtheria

Indication