Status:
COMPLETED
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18-49 years
Phase:
PHASE4
Brief Summary
* 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05329259
Start Date
October 6 2022
End Date
November 30 2022
Last Update
April 26 2024
Active Locations (5)
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1
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India, 395002
2
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, India, 560060
3
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, India, 305001
4
Calcutta School of Tropical Medicine
Kolkata, West Bengal, India, 700073