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. | Biotech Hunter

Enrollment

1,586

Participants

Timeline

Start Date

October 26, 2021

Primary Completion Date

June 6, 2022

Study Completion Date

June 6, 2022

Conditions

Respiratory Syncytial Virus Infections

Interventions

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.

Trial Locations (36)

15355

GSK Investigational Site, Gyeonggi-do

15706

GSK Investigational Site, Santiago de Compostela

20520

GSK Investigational Site, Turku

28006

GSK Investigational Site, Madrid

28034

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Pori

28222

GSK Investigational Site, Majadahonda (Madrid)

28922

GSK Investigational Site, Alcorcón/Madrid

30281

GSK Investigational Site, Stockbridge

33100

GSK Investigational Site, Tampere

33409

GSK Investigational Site, West Palm Beach

46015

GSK Investigational Site, Valencia

60100

GSK Investigational Site, Seinäjoki

61614

GSK Investigational Site, Peoria

65802

GSK Investigational Site, Springfield

67100

GSK Investigational Site, Kokkola

98105

GSK Investigational Site, Seattle

V3S 2N6

GSK Investigational Site, Surrey

V6Z 2T1

GSK Investigational Site, Vancouver

B2N 1L2

GSK Investigational Site, Truro

N5W 6A2

GSK Investigational Site, London

N7T 4X3

GSK Investigational Site, Sarnia

M9W 4L6

GSK Investigational Site, Toronto

J7J 2K8

GSK Investigational Site, Mirabel

H9R 4S3

GSK Investigational Site, Pointe-Claire

G1W 4R4

GSK Investigational Site, Québec

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

J1L 0H8

GSK Investigational Site, Sherbrooke

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

07441

GSK Investigational Site, Seoul

08308

GSK Investigational Site, Seoul