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A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults

Primary Purpose

Pneumococcal Infection

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LBVE01
LBVE02
Prevnar13
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infection

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult older than 19 years old and younger than 50 years old
  • A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form

Exclusion Criteria:

  • A subject who participated in other clinical studies within 3 months before screening
  • A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
  • A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
  • A subject who received immunoglobulin or blood-derived materials within 3 months before screening
  • A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
  • A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
  • A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
  • A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
  • A subject who was vaccinated with any pneumococcal vaccine before screening
  • A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    LBVE01

    LBVE02

    Prevnar13

    Arm Description

    Multivalent pneumococcal conjugate vaccine

    Multivalent pneumococcal conjugate vaccine

    Multivalent pneumococcal conjugate vaccine Prevnar13

    Outcomes

    Primary Outcome Measures

    Solicited adverse events
    Solicited adverse events
    Unsolicited adverse events
    Unsolicited adverse events
    Immediate reactions after vaccination
    Immediate reactions after vaccination

    Secondary Outcome Measures

    Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
    GMC
    Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
    GMT
    Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
    OPA titer

    Full Information

    First Posted
    May 25, 2018
    Last Updated
    June 11, 2018
    Sponsor
    LG Chem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03549208
    Brief Title
    A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
    Official Title
    Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2018 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    July 25, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Chem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    phase-1 study pneumococcal conjugate vaccine study in healthy adults
    Detailed Description
    A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumococcal Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LBVE01
    Arm Type
    Experimental
    Arm Description
    Multivalent pneumococcal conjugate vaccine
    Arm Title
    LBVE02
    Arm Type
    Experimental
    Arm Description
    Multivalent pneumococcal conjugate vaccine
    Arm Title
    Prevnar13
    Arm Type
    Active Comparator
    Arm Description
    Multivalent pneumococcal conjugate vaccine Prevnar13
    Intervention Type
    Biological
    Intervention Name(s)
    LBVE01
    Intervention Description
    Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
    Intervention Type
    Biological
    Intervention Name(s)
    LBVE02
    Intervention Description
    Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
    Intervention Type
    Biological
    Intervention Name(s)
    Prevnar13
    Intervention Description
    13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
    Primary Outcome Measure Information:
    Title
    Solicited adverse events
    Description
    Solicited adverse events
    Time Frame
    Baseline(pre-vaccination) up to 7 days after
    Title
    Unsolicited adverse events
    Description
    Unsolicited adverse events
    Time Frame
    Baseline(pre-vaccination) up to 4 weeks after vaccination
    Title
    Immediate reactions after vaccination
    Description
    Immediate reactions after vaccination
    Time Frame
    Baseline(pre-vaccination) up to 30 minutes after vaccination
    Secondary Outcome Measure Information:
    Title
    Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
    Description
    GMC
    Time Frame
    4 weeks After Vaccination
    Title
    Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
    Description
    GMT
    Time Frame
    4 weeks After Vaccination
    Title
    Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
    Description
    OPA titer
    Time Frame
    4 weeks after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adult older than 19 years old and younger than 50 years old A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form Exclusion Criteria: A subject who participated in other clinical studies within 3 months before screening A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients A subject who received immunoglobulin or blood-derived materials within 3 months before screening A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae A subject who was vaccinated with any pneumococcal vaccine before screening A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Soie Park
    Phone
    02-6987-4160
    Email
    soiep@lgchem.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myoung-don Oh, M.D.
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults

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