Who is sponsoring NCT05045144?

NCT05045144 is sponsored by GlaxoSmithKline.

What condition does NCT05045144 study?

NCT05045144 studies Respiratory Syncytial Virus Infections.

What drugs are being tested in NCT05045144?

Interventions: RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA), Placebo.

What is the status of NCT05045144?

NCT05045144 is currently COMPLETED.

Last reviewed 2023-10-05 · How we verify

A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

NCT05045144 PHASE3 COMPLETED Results posted

The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE3
Status	COMPLETED
Enrolment	1586
Start date	Tue Oct 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jun 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Respiratory Syncytial Virus Infections

Interventions

RSVPreF3(120 μg)
Flu Quadrivalent influenza vaccine (15 μg HA)
Placebo

Countries

Finland, South Korea, Canada, United States, Spain