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

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: Pneumococcal conjugate vaccine

• Registration Number: NCT02892812
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBVE014	Pneumococcal conjugate vaccine	14-valent pneumococcal conjugate vaccine
Prevnar13	Pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine
LBVE013	Pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Immediate reactions after vaccination	Baseline(pre-vaccination) up to 30 minutes after vaccination
Solicited adverse events	Baseline(pre-vaccination) up to 7 days after vaccination
Unsolicited adverse events	Baseline(pre-vaccination) up to 4 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 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
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination	4 weeks after vaccination

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of