A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

Who is this study for? Patients with Respiratory Syncytial Virus Infections
What treatments are being studied? RSVPreF3
Status: Completed
Location: See all (278) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF participants).

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

⁃ Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant

• Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.

• Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Locations
United States
Alabama
GSK Investigational Site
Birmingham
GSK Investigational Site
Birmingham
GSK Investigational Site
Huntsville
Arizona
GSK Investigational Site
Phoenix
GSK Investigational Site
Tucson
California
GSK Investigational Site
Cerritos
GSK Investigational Site
Laguna Hills
Florida
GSK Investigational Site
Coral Gables
GSK Investigational Site
Fort Myers
GSK Investigational Site
Jacksonville
GSK Investigational Site
Lake City
GSK Investigational Site
Melbourne
GSK Investigational Site
Miami
GSK Investigational Site
Orlando
GSK Investigational Site
Pinellas Park
GSK Investigational Site
The Villages
GSK Investigational Site
Weeki Wachee
GSK Investigational Site
West Palm Beach
Georgia
GSK Investigational Site
Atlanta
Illinois
GSK Investigational Site
Chicago
Indiana
GSK Investigational Site
Evansville
GSK Investigational Site
Mishawaka
Kansas
GSK Investigational Site
El Dorado
GSK Investigational Site
Newton
GSK Investigational Site
Wichita
GSK Investigational Site
Wichita
Kentucky
GSK Investigational Site
Lexington
Maryland
GSK Investigational Site
Rockville
Minnesota
GSK Investigational Site
Richfield
Missouri
GSK Investigational Site
Kansas City
GSK Investigational Site
Saint Louis
North Carolina
GSK Investigational Site
Hickory
GSK Investigational Site
Rocky Mount
GSK Investigational Site
Salisbury
GSK Investigational Site
Statesville
GSK Investigational Site
Winston-salem
Nebraska
GSK Investigational Site
Omaha
Nevada
GSK Investigational Site
Henderson
New York
GSK Investigational Site
Binghamton
GSK Investigational Site
Jamaica
GSK Investigational Site
Rochester
Ohio
GSK Investigational Site
Akron
GSK Investigational Site
Centerville
GSK Investigational Site
Cincinnati
GSK Investigational Site
Columbus
Pennsylvania
GSK Investigational Site
Erie
GSK Investigational Site
Pittsburgh
South Carolina
GSK Investigational Site
Anderson
GSK Investigational Site
Mount Pleasant
Tennessee
GSK Investigational Site
Knoxville
GSK Investigational Site
Memphis
Texas
GSK Investigational Site
Dallas
GSK Investigational Site
Fort Worth
GSK Investigational Site
Houston
GSK Investigational Site
Houston
GSK Investigational Site
Keller
GSK Investigational Site
San Antonio
Utah
GSK Investigational Site
Layton
GSK Investigational Site
Murray
Virginia
GSK Investigational Site
Norfolk
Other Locations
Australia
GSK Investigational Site
Botany
GSK Investigational Site
Camberwell
GSK Investigational Site
Coffs Harbour
GSK Investigational Site
Darlinghurst
GSK Investigational Site
Geelong
GSK Investigational Site
Morayfield
GSK Investigational Site
Murdoch
GSK Investigational Site
Taringa
GSK Investigational Site
Tarragindi
Belgium
GSK Investigational Site
Aalst
GSK Investigational Site
Alken
GSK Investigational Site
Edegem
GSK Investigational Site
Erpent
GSK Investigational Site
Genk
GSK Investigational Site
Gent
GSK Investigational Site
Ieper
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Mechelen
GSK Investigational Site
Tremelo
Canada
GSK Investigational Site
Chicoutimi
GSK Investigational Site
Edmonton
GSK Investigational Site
Halifax
GSK Investigational Site
London-ontario
GSK Investigational Site
Mirabel
GSK Investigational Site
New Westminster
GSK Investigational Site
Ottawa
GSK Investigational Site
Pointe-claire
GSK Investigational Site
Quebec
GSK Investigational Site
Sainte-foy
GSK Investigational Site
Sarnia
GSK Investigational Site
Sherbrooke
GSK Investigational Site
St-charles-borromee
GSK Investigational Site
Sudbury
GSK Investigational Site
Surrey
GSK Investigational Site
Toronto
GSK Investigational Site
Truro
GSK Investigational Site
Vancouver
GSK Investigational Site
Victoria
GSK Investigational Site
Victoria
Estonia
GSK Investigational Site
Paide
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu
Finland
GSK Investigational Site
Espoo
GSK Investigational Site
Helsinki
GSK Investigational Site
Helsinki
GSK Investigational Site
Jarvenpaa
GSK Investigational Site
Kokkola
GSK Investigational Site
Oulu
GSK Investigational Site
Pori
GSK Investigational Site
Seinajoki
GSK Investigational Site
Tampere
GSK Investigational Site
Turku
Germany
GSK Investigational Site
Berlin
GSK Investigational Site
Berlin
GSK Investigational Site
Berlin
GSK Investigational Site
Dachau
GSK Investigational Site
Dippoldiswalde
GSK Investigational Site
Dresden
GSK Investigational Site
Essen
GSK Investigational Site
Essen
GSK Investigational Site
Floersheim
GSK Investigational Site
Frankfurt
GSK Investigational Site
Freiberg
GSK Investigational Site
Freital
GSK Investigational Site
Goch
GSK Investigational Site
Hamburg
GSK Investigational Site
Hamburg
GSK Investigational Site
Hannover
GSK Investigational Site
Koeln
GSK Investigational Site
Leipzig
GSK Investigational Site
Leipzig
GSK Investigational Site
Mainz
GSK Investigational Site
Muenchen
GSK Investigational Site
Schenefeld
GSK Investigational Site
Wallerfing
GSK Investigational Site
Wangen
GSK Investigational Site
Weinheim
GSK Investigational Site
Witten
GSK Investigational Site
Wuerzburg
Italy
GSK Investigational Site
Alessandria
GSK Investigational Site
Bari
GSK Investigational Site
Belluno
GSK Investigational Site
Catanzaro
GSK Investigational Site
Chieri Torino
GSK Investigational Site
Ferrara
GSK Investigational Site
Genova
GSK Investigational Site
Milano
GSK Investigational Site
Milano
GSK Investigational Site
Napoli
GSK Investigational Site
Negrar Verona
GSK Investigational Site
Palermo
GSK Investigational Site
Pisa
GSK Investigational Site
Roma
GSK Investigational Site
Roma
GSK Investigational Site
Siena
GSK Investigational Site
Vercelli
Japan
GSK Investigational Site
Chiba
GSK Investigational Site
Hiroshima
GSK Investigational Site
Ibaraki
GSK Investigational Site
Kumamoto
GSK Investigational Site
Okinawa
GSK Investigational Site
Osaka
GSK Investigational Site
Saitama
GSK Investigational Site
Shizuoka
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Yamagata
GSK Investigational Site
Yamaguchi
Mexico
GSK Investigational Site
Chihuahua
GSK Investigational Site
Leon
GSK Investigational Site
Merida
GSK Investigational Site
Mexico City
GSK Investigational Site
Mexico City
GSK Investigational Site
Monterrey
GSK Investigational Site
Oaxaca
GSK Investigational Site
Queretaro
GSK Investigational Site
Rm Pharmamexico City
GSK Investigational Site
San Luis Potosi
New Zealand
GSK Investigational Site
Grafton Auckland
GSK Investigational Site
Havelock North
GSK Investigational Site
Kapiti
GSK Investigational Site
Palmerston North
GSK Investigational Site
Tauranga
GSK Investigational Site
Wellington
Poland
GSK Investigational Site
Czestochowa
GSK Investigational Site
Elblag
GSK Investigational Site
Gdansk
GSK Investigational Site
Gdynia
GSK Investigational Site
Katowice
GSK Investigational Site
Katowice
GSK Investigational Site
Katowice
GSK Investigational Site
Krakow
GSK Investigational Site
Lodz
GSK Investigational Site
Lodz
GSK Investigational Site
Piaseczno
GSK Investigational Site
Poznan
GSK Investigational Site
Warszawa
GSK Investigational Site
Warszawa
GSK Investigational Site
Warszawa
GSK Investigational Site
Wroclaw
GSK Investigational Site
Wroclaw
Republic of Korea
GSK Investigational Site
Ansan
GSK Investigational Site
Bucheon-si Kyunggi-do 14584
GSK Investigational Site
Daegu
GSK Investigational Site
Incheon
GSK Investigational Site
Jeonju
GSK Investigational Site
Kangwon-do
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon Gyeonggi-do
Russian Federation
GSK Investigational Site
Barnaul
GSK Investigational Site
Ekaterinburg
GSK Investigational Site
Gatchina
GSK Investigational Site
Kemerovo
GSK Investigational Site
Moscow
GSK Investigational Site
Saint-petersburg
GSK Investigational Site
Saint-petersburg
GSK Investigational Site
Stpetersburg
GSK Investigational Site
Stpetersburg
South Africa
GSK Investigational Site
Cape Town
GSK Investigational Site
Johannesburg
GSK Investigational Site
Johannesburg
GSK Investigational Site
Middelburg
GSK Investigational Site
Moloto South
GSK Investigational Site
Newcastle
GSK Investigational Site
Reiger Park
GSK Investigational Site
Tembisa
Spain
GSK Investigational Site
Alcorcon
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Santiago De Compostela
GSK Investigational Site
Valencia
United Kingdom
GSK Investigational Site
Bebington
GSK Investigational Site
Belfast
GSK Investigational Site
Birmingham
GSK Investigational Site
Bradford On Avon Wiltsh
GSK Investigational Site
Cardiff
GSK Investigational Site
Corby
GSK Investigational Site
Eynsham
GSK Investigational Site
Glasgow
GSK Investigational Site
Hardwick
GSK Investigational Site
Hexham
GSK Investigational Site
Lancashire
GSK Investigational Site
Leamington Spa
GSK Investigational Site
Liverpool
GSK Investigational Site
Manchester
GSK Investigational Site
Orpington
GSK Investigational Site
Oxford
GSK Investigational Site
Peterborough
GSK Investigational Site
Romford
GSK Investigational Site
Thetford Norfolk
GSK Investigational Site
Witney
Time Frame
Start Date: 2021-05-25
Completion Date: 2024-05-31
Participants
Target number of participants: 26668
Treatments
Experimental: RSVPreF3 Group
Participants in this group received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants were re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine before Season 2; participants in the other receiving a dose of placebo before Season 2.
Placebo_comparator: Placebo Group
Participants in this group received 1 dose of placebo at Day 1 and received an additional dose of placebo before Season 2.
Authors
Jacob Lee, William C Simon, Murray A. Kimmel, Mohammed A. Allaw, Brandon James Essink, Cornell V Calinescu, Michael R Adams, Cathy Greiwe, William P Jennings, David A Browder, Mark Adams, Gilbert Jenouri, Minesh Arun Patel, Margarita Nunez, Mark Bloch, Paul Nugent, Joseph Newberg, Bradley Swenson, Rickey Manning, Pedro P Ylisastigui, Oscar De Valle, Dalton M. Benson, Enrique Pelayo, Mira Baron, Lisa S Usdan, Troy Holdeman, Kenneth D. Chinsky, Paul Bradley, Randle T Middleton, Ernie Riffer, John E Ervin, Shari Rozen, Judith Brown, Naveen Garg, Jewel Johnny White, Shishir Khetan, Jeffery L DeGrauw, Jeffrey Klein, Jeffrey B. Rosen, Michael B Jones, Linda P. Murray, David D DeAtkine, Allan Kelly, Bruce Seaton, Michele D. Reynolds, Herman Jackson Downey, Ghazaleh Bahrami, Michael Rausch, Leslie Tharenos, Vivek Krishna, Tino F Schwarz, Judith L. White, Frank Schaper, Helen Nicholls, Tomas Jelinek, Brigitte Stephan, William E. Kirby, Meenakshi Patel, Sherif G Naguib, Gregory M Fuller, Wayne Ghesquiere, Carlo Pomari, Kenji Takazawa, Hyo Youl Kim, Muriel Lins, Rain Jogi, Ferdinandus de Looze, Ivo Valter, Erik Buntinx, Murdo Ferguson, Marc Dionne, Carlo Bruno Giorda, Svetlana Smakotina, Yong Chul Lee, Dagmara Borzych-Duzalka, Claudia Pileggi, Seong-Heon Wie, Wim Terryn, Richard Strawson Stubbs, Paul Bird, Essack Aziz Mitha, Isabel Leroux-Roels, Raffaele Antonelli Incalzi, Silvio Tafuri, Joanne Langley, Sean Peterson, Richard van Zyl-Smit, Donald William Cameron, Fabrizio Pregliasco, Eugene Athan, Dieter Mesotten, Jean-Benoît Martinot, Elena Bargagli, Giancarlo Icardi, Alberto Papi, Kathryn Mngadi
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

Similar Clinical Trials