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

LG Chem

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Biological: Pentavalent vaccine and Inactivated Polio vaccine; Biological: LBVD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06947499

LG-VDCL004

Details and patient eligibility

About

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

Full description

Stage 1 (Phase 2)

1. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Stage 2 (Phase 3)

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

Enrollment: 1,186 estimated patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,186 participants in 5 patient groups

Test group 1 for Stage 1

Experimental group

Description:

LBVD

Treatment:

Biological: LBVD

Test group 1 for Stage 2

Experimental group

Description:

LBVD Lot A

Treatment:

Biological: LBVD

Test group 2 for Stage 2

Experimental group

Description:

LBVD Lot B

Treatment:

Biological: LBVD

Test group 3 for Stage 2

Experimental group

Description:

LBVD Lot C

Treatment:

Biological: LBVD

Control group for Stage 1 and Stage 2

Active Comparator group

Description:

Co-administration of Pentavalent vaccine and Inactivated Polio vaccine

Treatment:

Biological: Pentavalent vaccine and Inactivated Polio vaccine