Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473519
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-17
Brief Title:
A Study to Assess Safety Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 3 RANDOMIZED OPEN-LABEL TRIAL TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS RSV PREFUSION F SUBUNIT VACCINE FORMULATED IN MULTIDOSE VIALS IN HEALTHY FEMALE ADULTS
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Amélie
Brief Summary:
Respiratory Syncytial Virus RSV is a common type of virus germ that can cause severe illness where medical help is needed RSV can lead to airway diseases in all ages Vaccines help your body make antibodies These antibodies help fight against diseases This is called an immune response
The purpose of this study is to learn about the safety tolerability and immunogenicity of a RSV vaccine called RSVpreF RSVpreF comes either as
a single dose in a container called a vial
or in a vial that holds multiple doses A multidose vial contains more than one dose of RSVpreF
2-Phenoxyethanol 2-PE is a preservative to help prevent the growth of bacteria germs This study will compare RSVpreF with an added preservative called 2-phenoxyethanol 2-PE from a multidose vial to RSVpreF without an added preservative from a single-dose vial
This study is looking to enroll nonpregnant nonbreastfeeding healthy female participants
Participants will need to visit the study clinic two times during the study Participants will also have a final safety telephone call at the end of the study All participants will receive a single shot of the study vaccine either from
a multidose vial with the preservative or
from a single-dose vial without the preservative at the first study clinic visit
Blood samples will be taken at the two study clinic visits Each participant will take part in the study for around 6 weeks
The purpose of this study is to learn about the safety tolerability and immunogenicity of a RSV vaccine called RSVpreF RSVpreF comes either as
a single dose in a container called a vial
or in a vial that holds multiple doses A multidose vial contains more than one dose of RSVpreF
2-Phenoxyethanol 2-PE is a preservative to help prevent the growth of bacteria germs This study will compare RSVpreF with an added preservative called 2-phenoxyethanol 2-PE from a multidose vial to RSVpreF without an added preservative from a single-dose vial
This study is looking to enroll nonpregnant nonbreastfeeding healthy female participants
Participants will need to visit the study clinic two times during the study Participants will also have a final safety telephone call at the end of the study All participants will receive a single shot of the study vaccine either from
a multidose vial with the preservative or
from a single-dose vial without the preservative at the first study clinic visit
Blood samples will be taken at the two study clinic visits Each participant will take part in the study for around 6 weeks
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