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NCT Number: NCT05457946

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

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)

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type B Infection Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Pertussis Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Stage 1 (Dose-level Finding;Phase 2)

  • 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)

  • 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
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBVD (Hexavalent vaccine)

Biological

Injection within the muscle into the front area of the thigh

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Biological

Injection within the muscle into the front area of the thigh

Primary outcomes

  1. Seroprotection/seroconservison/ vaccine-response rate

    Time frame: 4 weeks after three-dose primary series

    Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

Secondary outcomes

  1. Geometric mean concentration (GMC) or Geometric mean titer (GMT)

    Time frame: 4 weeks after three-dose primary series

    GMC or GMT and their ratio of all types of antibodies

  2. Immediate reactions after vaccination

    Time frame: 30 minutes after each 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.

  3. Solicited adverse event

    Time frame: 7 days after each vaccination

    Expected local or systemic side effects after vaccination

  4. Unsolicited adverse event

    Time frame: 28 days after each vaccinations

    All unwanted or bad events after vaccination other than solicited adverse event

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2022
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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