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

Study Overview
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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.

Official Title
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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

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Pneumococcal conjugate vaccine


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBVE013<br>13-valent pneumococcal conjugate vaccine | Biological: Pneumococcal conjugate vaccine<br> <br> |
| Experimental: LBVE014<br>14-valent pneumococcal conjugate vaccine | Biological: Pneumococcal conjugate vaccine<br> <br> |
| Active Comparator: Prevnar13<br>13-valent pneumococcal conjugate vaccine | Biological: Pneumococcal conjugate vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited adverse events |  | Baseline(pre-vaccination) up to 7 days after vaccination | 
| Unsolicited adverse events |  | Baseline(pre-vaccination) up to 4 weeks 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 Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination |  | 4 weeks after vaccination | 
| Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination |  | 4 weeks after vaccination | 
| Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination |  | 4 weeks after vaccination |