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

Phase 1

• Conditions: Pneumococcal Infection
• Interventions: Biological: Prevnar13; Biological: LBVE01; Biological: LBVE02

• Registration Number: NCT03549208
• Lead Sponsor: LG Chem

Brief Summary

phase-1 study pneumococcal conjugate vaccine study in healthy adults

Detailed Description

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

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-07
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13
• Study Start: 2018-07-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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
Prevnar13	Prevnar13	Multivalent pneumococcal conjugate vaccine Prevnar13
LBVE01	LBVE01	Multivalent pneumococcal conjugate vaccine
LBVE02	LBVE02	Multivalent pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Solicited adverse events	Baseline(pre-vaccination) up to 7 days after	Solicited adverse events
Unsolicited adverse events	Baseline(pre-vaccination) up to 4 weeks after vaccination	Unsolicited adverse events
Immediate reactions after vaccination	Baseline(pre-vaccination) up to 30 minutes after vaccination	Immediate reactions 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	GMT
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination	4 weeks after vaccination	OPA titer
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination	4 weeks After Vaccination	GMC