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

Phase 1

• Conditions: Pneumococcal Infection

• 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

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