A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults

Study Overview
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Brief Summary
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The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease. This study will happen in in 2 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle. Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided. Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle. Participants will take part in this study for about 6 months for Stage 1 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.

Official Title
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A Phase 1/2, Randomized, Double-Blind Trial of the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: Multivalent Pneumococcal Vaccine - Formulation 1
* Biological: Multivalent Pneumococcal Vaccine - Formulation 2
* Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2) at the time of consent Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) Phase 2 (Stage 2): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced) Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study Known or suspected immunodeficiency or other conditions associated with immunosuppression Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1<br>Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2). | Biological: Multivalent Pneumococcal Vaccine - Formulation 1<br>* Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stage 2).<br>|
| Experimental: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2<br>Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2). | Biological: Multivalent Pneumococcal Vaccine - Formulation 2<br>* Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stage 2).<br>|
| Active Comparator: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)<br>Participants to receive a single injection of 20vPnC. | Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)<br>* 20-valent pneumococcal conjugate vaccine (20vPnC)<br>* Other names: Prevnar 20;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting prespecified local reactions within 7 days after vaccination | Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination | 7 days | 
| Percentage of participants reporting prespecified systemic events within 7 days after vaccination | Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination | 7 days | 
| Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination | Adverse events occurring within 1 month after vaccination | 1 month | 
| Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination | SAEs occurring within 6 months after vaccination | 6 months | 
| Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination | Related SAEs occurring through 12 months after vaccination | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) | Pneumococcal OPA GMTs 1 month after vaccination | 1 month after vaccination |