Back to resultsA Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Nirmal Hospital Pvt Ltd.
- BGS Global Institute of Medical Sciences (BGSGIMS)
- Jawahar Lal Nehru Medical College
- Calcutta School of Tropical Medicine
- Aakash Healthcare Private Limited
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
13-valent pneumococcal conjugate vaccine
Arm Description
Pneumococcal conjugate vaccine (13vPnC)
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, fatigue, headache, muscle pain and joint pain) after vaccination
Percentage of participants reporting adverse events (AEs) within 1 month after vaccination
Adverse events (AEs) occurring within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) within 1 month after vaccination
Serious adverse events (SAEs) occurring within 1 month after vaccination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05329259
Brief Title
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Official Title
A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 adults ≥18 and <50 years of age, with no prior history of pneumococcal vaccination.
Participants will take part in the study for approximately one month which includes two visits to the study clinic.
Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
13-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine (13vPnC)
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
One dose of 13vPnC (0.5mL) 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, fatigue, headache, muscle pain and joint pain) after vaccination
Time Frame
7 days
Title
Percentage of participants reporting adverse events (AEs) within 1 month after vaccination
Description
Adverse events (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
Serious adverse events (SAEs) occurring within 1 month after vaccination
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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
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
Jawahar Lal Nehru Medical College
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Facility Name
Calcutta School of Tropical Medicine
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700073
Country
India
Facility Name
Aakash Healthcare Private Limited
City
Delhi
ZIP/Postal Code
110075
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=B1851214
Description
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Learn more about this trial
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
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