Clinical trial NCT06947499: 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
Official title: A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical 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 (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type b
Keywords: vaccination
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 1186
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Seroprotection/seroconversion rate
timeFrame: 4 weeks after a three-dose primary series
measure: Geometric mean concentration (GMC) for pertussis
timeFrame: 4 weeks after a three-dose primary series
Secondary outcomes:
measure: Geometric mean titer (GMT) or GMC
timeFrame: 4 weeks after the three-dose primary series
measure: Seroprotection/seroconversion rate
timeFrame: 4 weeks after the three-dose primary series
measure: Immediate reactions after vaccination
timeFrame: 30 minutes after each vaccination
measure: Solicited adverse event
timeFrame: within 7 days after each vaccination
measure: Unsolicited adverse event
timeFrame: 4 weeks after the three-dose primary series
Other outcomes:
Locations:
city: Dasmarinas
country: Philippines
facility: Care CT Group
state: Cavite
Study officials:
References: