Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-25 @ 1:26 AM
Study NCT ID:
NCT05329259
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2022-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Sponsor:
Pfizer
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: