At a glance
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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.
In Brief
A Phase 3 clinical trial evaluating RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA), and 1 other intervention for Respiratory Syncytial Virus Infections. Completed, enrolled 1,586 participants across 36 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.