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NCT05875727 | COMPLETED | Pneumococcal Disease

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

Pfizer

Brief Summary:

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.

Condition or disease

Pneumococcal Disease

Intervention/treatment

20-valent pneumococcal conjugate vaccine

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 405 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA
Actual Study Start Date : 2023-08-16
Estimated Primary Completion Date : 2023-10-02
Estimated Study Completion Date : 2023-10-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

Location Details

NCT05875727

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

India, Delhi

Aakash Healthcare Private Limited

New Delhi, Delhi, India, 110075

Not yet recruiting

India, Gujarat

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, India, 395002

Not yet recruiting

India, Karnataka

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, India, 560060

Not yet recruiting

India, Karnataka

RajaRajeswari Medical College and Hospital

Bangalore, Karnataka, India, 560074

Not yet recruiting

India, Karnataka

RajaRajeswari Medical College and Hospital

Bengaluru, Karnataka, India, 560074

Not yet recruiting

India, Maharashtra

Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre

Pune, Maharashtra, India, 411043

Not yet recruiting

India, Rajasthan

Jawahar Lal Nehru Hospital

Ajmer, Rajasthan, India, 305001

Not yet recruiting

India, Rajasthan

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, India, 305001