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

Pneumococcal Infections Clinical Trial

Official title:

A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892812
• Other study ID #: LG-VECL001
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2016
• Last updated: June 23, 2017
• Start date: September 2016
• Est. completion date: November 2016

Study information

• Verified date: June 2017
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• 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 Infections

Intervention

Biological:
• Pneumococcal conjugate vaccine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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