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

January 11, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110075
        • Aakash Healthcare Private Limited
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560060
        • BGS Global Institute of Medical Sciences (BGSGIMS)
      • Bangalore, Karnataka, India, 560074
        • RajaRajeswari Medical College and Hospital
      • Bengaluru, Karnataka, India, 560074
        • RajaRajeswari Medical College and Hospital
    • Maharashtra
      • Pune, Maharashtra, India, 411043
        • Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Jawahar Lal Nehru Medical College
      • Ajmer, Rajasthan, India, 305001
        • Jawahar Lal Nehru Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (20vPnC)
One dose of 20vPnC will be administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting prompted local reactions within 7 days after vaccination
Time Frame: 7 days
Prompted local reactions (redness, swelling, and pain at the injection site) after vaccination
7 days
Percentage of participants reporting prompted systemic events within 7 days after vaccination
Time Frame: 7 days
Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after vaccination
7 days
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Time Frame: 1 month
AEs occurring within 1 month after vaccination
1 month
Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after vaccination
Time Frame: 1 month
SAEs occurring within 1 month after vaccination
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR)
Time Frame: 1 month
GMFR in OPA titers from before vaccination to 1 month after vaccination
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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