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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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LBVE013

13-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

LBVE014

14-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Prevnar13

13-valent pneumococcal conjugate vaccine

Group Type ACTIVE_COMPARATOR

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Interventions

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Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes