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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2023-10-02

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.

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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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20-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine (20vPnC)

Group Type EXPERIMENTAL

20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

One dose of 20vPnC will be administered intramuscularly.

Interventions

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20-valent pneumococcal conjugate vaccine

One dose of 20vPnC will be administered intramuscularly.

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes