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

Pneumococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03549208
• Other study ID #: LG-VECL003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2018
• Est. completion date: July 25, 2019

Study information

• Verified date: May 2018
• Source: LG Chem
• Contact: Soie Park
• Phone: 02-6987-4160
• Email: soiep[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

phase-1 study pneumococcal conjugate vaccine study in healthy adults

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 25, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• LBVE01
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
• LBVE02
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
• Prevnar13
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

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