Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549208
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
LG Chem

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 13, 2018
Estimated Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Solicited adverse events [ Time Frame: Baseline(pre-vaccination) up to 7 days after ]
    Solicited adverse events
  • Unsolicited adverse events [ Time Frame: Baseline(pre-vaccination) up to 4 weeks after vaccination ]
    Unsolicited adverse events
  • Immediate reactions after vaccination [ Time Frame: Baseline(pre-vaccination) up to 30 minutes after vaccination ]
    Immediate reactions after vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03549208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMC
  • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMT
  • Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    OPA titer
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMC
  • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMT
  • Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    OPA titer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infection
Intervention  ICMJE
  • Biological: LBVE01
    Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
  • Biological: LBVE02
    Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
  • Biological: Prevnar13
    13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Study Arms  ICMJE
  • Experimental: LBVE01
    Multivalent pneumococcal conjugate vaccine
    Intervention: Biological: LBVE01
  • Experimental: LBVE02
    Multivalent pneumococcal conjugate vaccine
    Intervention: Biological: LBVE02
  • Active Comparator: Prevnar13
    Multivalent pneumococcal conjugate vaccine Prevnar13
    Intervention: Biological: Prevnar13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 25, 2019
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Soie Park 02-6987-4160 soiep@lgchem.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549208
Other Study ID Numbers  ICMJE LG-VECL003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LG Chem
Study Sponsor  ICMJE LG Chem
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
PRS Account LG Chem
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP