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

Primary Purpose

Pneumococcal Disease

Status
Active
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Aakash Healthcare Private Limited
  • Nirmal Hospital Pvt Ltd.
  • BGS Global Institute of Medical Sciences (BGSGIMS)
  • RajaRajeswari Medical College and Hospital
  • Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre
  • Jawahar Lal Nehru Hospital
  • Jawahar Lal Nehru Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

20-valent pneumococcal conjugate vaccine

Arm Description

Pneumococcal conjugate vaccine (20vPnC)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR)
GMFR in OPA titers from before vaccination to 1 month after vaccination

Full Information

First Posted
May 16, 2023
Last Updated
October 6, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05875727
Brief Title
A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
October 2, 2023 (Actual)
Study Completion Date
October 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine (20vPnC)
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine
Intervention Description
One dose of 20vPnC will be administered intramuscularly.
Primary Outcome Measure Information:
Title
Percentage of participants reporting prompted local reactions within 7 days after vaccination
Description
Prompted local reactions (redness, swelling, and pain at the injection site) after vaccination
Time Frame
7 days
Title
Percentage of participants reporting prompted systemic events within 7 days after vaccination
Description
Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after vaccination
Time Frame
7 days
Title
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Description
AEs occurring within 1 month after vaccination
Time Frame
1 month
Title
Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after vaccination
Description
SAEs occurring within 1 month after vaccination
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR)
Description
GMFR in OPA titers from before vaccination to 1 month after vaccination
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Aakash Healthcare Private Limited
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110075
Country
India
Facility Name
Nirmal Hospital Pvt Ltd.
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
BGS Global Institute of Medical Sciences (BGSGIMS)
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560060
Country
India
Facility Name
RajaRajeswari Medical College and Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560074
Country
India
Facility Name
Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411043
Country
India
Facility Name
Jawahar Lal Nehru Hospital
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Facility Name
Jawahar Lal Nehru Medical College
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471010
Description
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A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

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