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

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Infections

Treatments: Biological: Pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02892812

LG-VECL001

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

63 participants in 3 patient groups

LBVE013

Experimental group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Biological: Pneumococcal conjugate vaccine

LBVE014

Experimental group

Description:

14-valent pneumococcal conjugate vaccine

Treatment:

Biological: Pneumococcal conjugate vaccine

Prevnar13

Active Comparator group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Biological: Pneumococcal conjugate vaccine