NCT05045144

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.

A Phase III, Randomized, Multi-country Study to Evaluate the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK's Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,586 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	RSVPreF3(120 μg)	A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
COMBINATION_PRODUCT	Flu Quadrivalent influenza vaccine (15 μg HA)	A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
COMBINATION_PRODUCT	Placebo	One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2021-09-16
• Last updated: 2023-10-05
• Results posted: 2023-10-05

Locations

36 sites across 5 countries: United States, Canada, Finland, South Korea, Spain

Regulatory

• FDA-regulated drug study