Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

Study Overview
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Brief Summary
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This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.

Official Title
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A PHASE 1B, RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINES IN HEALTHY JAPANESE ADULTS 18 TO 49 YEARS OF AGE

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Prevnar 13
* Biological: multivalent pneumococcal conjugate formulation 1
* Biological: multivalent pneumococcal conjugate formulation 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or interview) Exclusion Criteria: Participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevnar 13<br>13 valent Pneumococcal Conjugate | Biological: Prevnar 13<br>* 13 valent Pneumococcal Conjugate<br>|
| Experimental: multivalent pneumococcal conjugate formulation 1<br>multivalent pneumococcal conjugate formulation 1 | Biological: multivalent pneumococcal conjugate formulation 1<br>* multivalent pneumococcal conjugate formulation 1<br>|
| Experimental: multivalent pneumococcal conjugate formulation 2<br>multivalent pneumococcal conjugate formulation 2 | Biological: multivalent pneumococcal conjugate formulation 2<br>* multivalent pneumococcal conjugate formulation 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site). | Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site). | 14 days after vaccination | 
| Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). | Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). | 14 days after vaccination | 
| Subjects reporting adverse events (AEs) within 1 month after vaccination. | Subjects reporting adverse events (AEs) within 1 month after vaccination. | 1 month after vaccination | 
| Subjects reporting serious adverse events (SAEs) within 6 months after vaccination. | Subjects reporting serious adverse events (SAEs) within 6 months after vaccination. | 6 months after vaccination | 
| Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. | Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. | 6 months after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Pneumococcal serotype-specific OPA titers 1 month after vaccination. | 1 month after vaccination |