Clinical trial NCT05457946: Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type B Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 1438
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 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)

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

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

Primary outcomes:
measure: Seroprotection/seroconservison/ vaccine-response rate
timeFrame: 4 weeks after three-dose primary series
Secondary outcomes:
measure: Geometric mean concentration (GMC) or Geometric mean titer (GMT)
timeFrame: 4 weeks after three-dose primary series
measure: Immediate reactions after vaccination
timeFrame: 30 minutes after each vaccination
measure: Solicited adverse event
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse event
timeFrame: 28 days after each vaccinations
Other outcomes:
Locations:
Study officials:
affiliation: Health Index Multispecialty Clinic
name: Edison Alberto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UERM Memorial Medical Center
name: Josefina Carlos, MD
role: PRINCIPAL_INVESTIGATOR
References: