NCT02892812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

September 2, 2016

Last Update Submit

June 23, 2017

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (3)

  • Solicited adverse events

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

  • Unsolicited adverse events

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

  • Immediate reactions after vaccination

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

Secondary Outcomes (3)

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

    4 weeks after vaccination

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

    4 weeks after vaccination

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

    4 weeks after vaccination

Study Arms (3)

LBVE013

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: Pneumococcal conjugate vaccine

LBVE014

EXPERIMENTAL

14-valent pneumococcal conjugate vaccine

Biological: Pneumococcal conjugate vaccine

Prevnar13

ACTIVE COMPARATOR

13-valent pneumococcal conjugate vaccine

Biological: Pneumococcal conjugate vaccine

Interventions

Pneumococcal conjugate vaccineBIOLOGICAL
LBVE013LBVE014Prevnar13

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Myoung-don Oh, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

KR(1)