A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India

Study Overview
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Brief Summary
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The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India. This study is seeking participants who are generally healthy adults ≥18 and <50 years of age, with no prior history of pneumococcal vaccination. Participants will take part in the study for approximately one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.

Official Title
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A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: 13-valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy participants between the ages of ≥18 and <50 years at the time of consent. Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid-containing vaccine. Congenital, functional, or surgical asplenia. 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
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13-valent pneumococcal conjugate vaccine<br>Pneumococcal conjugate vaccine (13vPnC) | Biological: 13-valent pneumococcal conjugate vaccine<br>* One dose of 13vPnC (0.5mL) 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, fatigue, headache, muscle pain and joint pain) after vaccination | 7 days | 
| Percentage of participants reporting adverse events (AEs) within 1 month after vaccination | Adverse events (AEs) occurring within 1 month after vaccination | 1 month | 
| Percentage of participants reporting serious adverse events (SAEs) within 1 month after vaccination | Serious adverse events (SAEs) occurring within 1 month after vaccination | 1 month |