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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02892812

Enrollment

Registered

2016-09-08

Start date

2016-09-30

Completion date

2016-11-30

Last updated

2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

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.

Interventions

BIOLOGICALPneumococcal conjugate vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026