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A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

Primary Purpose

Pneumococcal Infections

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pneumococcal conjugate vaccine

About this trial

This is an interventional prevention trial for Pneumococcal Infections

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

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

LBVE013

LBVE014

Prevnar13

Arm Description

13-valent pneumococcal conjugate vaccine

14-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

Solicited adverse events

Unsolicited adverse events

Immediate reactions after vaccination

Secondary Outcome Measures

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination

Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination

Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination

Full Information

NCT ID

NCT02892812

First Posted

September 2, 2016

Last Updated

June 23, 2017

Sponsor

LG Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02892812

Brief Title

A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

Official Title

A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Life Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.

6. Conditions and Keywords

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

Pneumococcal Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LBVE013

Arm Type

Experimental

Arm Description

13-valent pneumococcal conjugate vaccine

Arm Title

LBVE014

Arm Type

Experimental

Arm Description

14-valent pneumococcal conjugate vaccine

Arm Title

Prevnar13

Arm Type

Active Comparator

Arm Description

13-valent pneumococcal conjugate vaccine

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate vaccine

Primary Outcome Measure Information:

Title

Solicited adverse events

Time Frame

Baseline(pre-vaccination) up to 7 days after vaccination

Title

Unsolicited adverse events

Time Frame

Baseline(pre-vaccination) up to 4 weeks after vaccination

Title

Immediate reactions after vaccination

Time Frame

Baseline(pre-vaccination) up to 30 minutes after vaccination

Secondary Outcome Measure Information:

Title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination

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

Time Frame

4 weeks after vaccination

Title

Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination

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

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)

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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

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