- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875727
A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7471010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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