Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325657
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-08
Brief Title:
A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 3 RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS RSV PREFUSION F SUBUNIT VACCINE IN PREGNANT PARTICIPANTS LIVING WITH HIV AND THEIR INFANTS
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MORISOT
Brief Summary:
The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine It will be studied in infants born to mothers living with HIV These infants may have higher chances of getting sick or dying due to RSV infection Respiratory Syncytial Virus RSV is a common type of virus germ that can cause severe illness airway diseases where medical help is needed Vaccines help your body make antibodies which help fight against diseases The antibodies are substances your body uses to fight off an infection The antibodies can be passed to the infant through the placenta of the mother
The study will look at the safety tolerability and immune activity in mothers and their infants
This study is seeking pregnant women who are
Less than or equal to 49 years old and have HIV Human immunodeficiency virus -
Receiving standard medical care during the pregnancy
Do not have syphilis bacterial sexually transmitted disease Hepatitis B Virus HBV liver infection Tuberculosis TB bacterial lung infection
Have been on stable anti-retroviral HIV treatment for more than or equal to 90 days
agree to be present for all study visits procedures and blood draws
Participants will either receive
RSVpreF vaccine
A placebo A placebo does not have any medicine it but looks just like the study vaccine
Pregnant participants will be involved in the study from
consent during their current pregnancy and
for 6 months after delivery of their baby around 10 months in total Pregnant participants will have at least 5 planned visits in this study Infant participants All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months Infant participants will have at least 3 study visits with some site visits allowed to happen via home visits or over the telephone
The study will look at the safety tolerability and immune activity in mothers and their infants
This study is seeking pregnant women who are
Less than or equal to 49 years old and have HIV Human immunodeficiency virus -
Receiving standard medical care during the pregnancy
Do not have syphilis bacterial sexually transmitted disease Hepatitis B Virus HBV liver infection Tuberculosis TB bacterial lung infection
Have been on stable anti-retroviral HIV treatment for more than or equal to 90 days
agree to be present for all study visits procedures and blood draws
Participants will either receive
RSVpreF vaccine
A placebo A placebo does not have any medicine it but looks just like the study vaccine
Pregnant participants will be involved in the study from
consent during their current pregnancy and
for 6 months after delivery of their baby around 10 months in total Pregnant participants will have at least 5 planned visits in this study Infant participants All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months Infant participants will have at least 3 study visits with some site visits allowed to happen via home visits or over the telephone
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