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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Pneumococcal Disease

Treatments

Biological: 13-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

B1851214

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.