Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-24
Brief Title:
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A STUDY TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 learn if modified RNA modRNA vaccines for the prevention of influenza are
safe and
how these vaccines produce an immune response in generally healthy adults Immune response is the way the body protects itself against things it sees as harmful or foreign
RNA also called ribonucleic acid is one of two types of nucleic acid made by cells RNA contains information that has been copied from DNA the other type of nucleic acid Cells make several different forms of RNA and each form has a specific job in the cell Many forms of RNA have functions related to making proteins RNA is also the genetic material of some viruses instead of DNA RNA can be made in the laboratory and used in research studies Also called ribonucleic acid
Influenza is term used for flu illness It is an infection caused by a virus that affects your mouth nose and throat
The study is seeking for participants who
are at least 18 years of age
have not received an influenza vaccine within the last 6 months
are generally healthy
This study will be divided into three sub-studies Substudy A SSA Substudy B SSB and Substudy C SSC
All participants regardless of sub-study will receive 1 dose of either of the following vaccines as an injection into their arm
1 of the modRNA influenza vaccines that is being studied or
an approved influenza vaccine approved for use in their respective age group
Participants will be involved in this study for about 6 months During this time participants will have at least 3 clinic visits
safe and
how these vaccines produce an immune response in generally healthy adults Immune response is the way the body protects itself against things it sees as harmful or foreign
RNA also called ribonucleic acid is one of two types of nucleic acid made by cells RNA contains information that has been copied from DNA the other type of nucleic acid Cells make several different forms of RNA and each form has a specific job in the cell Many forms of RNA have functions related to making proteins RNA is also the genetic material of some viruses instead of DNA RNA can be made in the laboratory and used in research studies Also called ribonucleic acid
Influenza is term used for flu illness It is an infection caused by a virus that affects your mouth nose and throat
The study is seeking for participants who
are at least 18 years of age
have not received an influenza vaccine within the last 6 months
are generally healthy
This study will be divided into three sub-studies Substudy A SSA Substudy B SSB and Substudy C SSC
All participants regardless of sub-study will receive 1 dose of either of the following vaccines as an injection into their arm
1 of the modRNA influenza vaccines that is being studied or
an approved influenza vaccine approved for use in their respective age group
Participants will be involved in this study for about 6 months During this time participants will have at least 3 clinic visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None