A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

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 response of 20vPnC in adults in India. This study is seeking participants who: are generally healthy adults of 18 years or older. have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Official Title
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A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: 20-valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Generally healthy participants ≥18 years of age at the time of consent. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine. Known or suspected immune deficiency or suppression. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20-valent pneumococcal conjugate vaccine<br>Pneumococcal conjugate vaccine (20vPnC) | Biological: 20-valent pneumococcal conjugate vaccine<br>* One dose of 20vPnC will be administered intramuscularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting prompted local reactions within 7 days after vaccination | Prompted local reactions (redness, swelling, and pain at the injection site) after vaccination | 7 days | 
| Percentage of participants reporting prompted systemic events within 7 days after vaccination | Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after vaccination | 7 days | 
| Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination | AEs occurring within 1 month after vaccination | 1 month | 
| Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after vaccination | SAEs occurring within 1 month after vaccination | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR) | GMFR in OPA titers from before vaccination to 1 month after vaccination | 1 month |