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

Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults

phase-1 study pneumococcal conjugate vaccine study in healthy adults

Study Overview

• Status: Unknown
• Conditions: Pneumococcal Infection
• Intervention / Treatment: Biological: LBVE01; Biological: LBVE02; Biological: Prevnar13

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Soie Park; Phone Number: 02-6987-4160; Email: soiep@lgchem.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBVE01; Multivalent pneumococcal conjugate vaccine	Biological: LBVE01; Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Experimental: LBVE02; Multivalent pneumococcal conjugate vaccine	Biological: LBVE02; Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Active Comparator: Prevnar13; Multivalent pneumococcal conjugate vaccine Prevnar13	Biological: Prevnar13; 13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited adverse events	Solicited adverse events	Baseline(pre-vaccination) up to 7 days after
Unsolicited adverse events	Unsolicited adverse events	Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination	Immediate reactions after vaccination	Baseline(pre-vaccination) up to 30 minutes after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination	GMC	4 weeks After Vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination	GMT	4 weeks After Vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination	OPA titer	4 weeks after vaccination

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): July 25, 2019

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: LG-VECL003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No