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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Disease

Treatments

Biological: 20-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05875727

B7471010

Details and patient eligibility

About

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.

Enrollment

405 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.