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

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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

Brief Summary:
phase-1 study pneumococcal conjugate vaccine study in healthy adults

Condition or disease Intervention/treatment Phase
Pneumococcal Infection Biological: LBVE01 Biological: LBVE02 Biological: Prevnar13 Phase 1

Detailed Description:
A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : July 25, 2019


Arm Intervention/treatment
Experimental: LBVE01
Multivalent pneumococcal conjugate vaccine
Biological: LBVE01
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Experimental: LBVE02
Multivalent pneumococcal conjugate vaccine
Biological: LBVE02
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Active Comparator: Prevnar13
Multivalent pneumococcal conjugate vaccine Prevnar13
Biological: Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh




Primary Outcome Measures :
  1. Solicited adverse events [ Time Frame: Baseline(pre-vaccination) up to 7 days after ]
    Solicited adverse events

  2. Unsolicited adverse events [ Time Frame: Baseline(pre-vaccination) up to 4 weeks after vaccination ]
    Unsolicited adverse events

  3. Immediate reactions after vaccination [ Time Frame: Baseline(pre-vaccination) up to 30 minutes after vaccination ]
    Immediate reactions after vaccination


Secondary Outcome Measures :
  1. Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMC

  2. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination [ Time Frame: 4 weeks After Vaccination ]
    GMT

  3. 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



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549208


Contacts
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Contact: Soie Park 02-6987-4160 soiep@lgchem.com

Sponsors and Collaborators
LG Chem
Investigators
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Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03549208     History of Changes
Other Study ID Numbers: LG-VECL003
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs