Clinical trial • Phase III • Infectious Disease|Respiratory

RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Respiratory syncytial virus infection

Phase III trial of RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Respirat…

Overview

Trial Therapeutic Area
Infectious Disease|Respiratory
Trial Disease
Respiratory syncytial virus infection
Trial Stage
Phase III
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
23-02-2024
First CTIS Authorization Date
06-06-2024

Trial design

Randomised, open-label, rsv_pres4 group: single revaccination dose of rsvpref3 oa vaccine before rsv season 4; rsv_pres5 group: single revaccination dose of rsvpref3 oa vaccine before rsv season 5; rsv_1dose group: no additional dose; crossover group: participants from parent study placebo group receive a single rsvpref3 oa vaccine dose at visit 1. (no external active comparator; comparisons are between timing/absence of revaccination.)-controlled, crossover Phase III trial in Belgium, Estonia, Finland and others.

Randomised
Yes
Open Label
Yes
Comparator
RSV_PreS4 group: single revaccination dose of RSVPreF3 OA vaccine before RSV Season 4; RSV_PreS5 group: single revaccination dose of RSVPreF3 OA vaccine before RSV Season 5; RSV_1dose group: no additional dose; Crossover group: participants from parent study placebo group receive a single RSVPreF3 OA vaccine dose at Visit 1. (No external active comparator; comparisons are between timing/absence of revaccination.)
Crossover
Yes
Target Sample Size
7382
Trial Duration For Participant
730

Eligibility

Recruits 7382 Vulnerable-population considerations: Vulnerable populations are addressed via written or witnessed informed consent requirement ("- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure."). Caregivers are explicitly allowed to assist participants who are physically incapable of self-completing diary cards (inclusion criterion text permits site staff assistance during visits or assignment of a caregiver for at-home activities) but caregivers/site staff must not evaluate participant health or make decisions on participant's behalf. Participants with dementia or conditions that moderately/severely impair cognition are excluded (explicit exclusion). Dedicated caregiver information letters and caregiver ICFs are provided in the study documents..

Vulnerable Population
Vulnerable-population considerations: Vulnerable populations are addressed via written or witnessed informed consent requirement ("- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure."). Caregivers are explicitly allowed to assist participants who are physically incapable of self-completing diary cards (inclusion criterion text permits site staff assistance during visits or assignment of a caregiver for at-home activities) but caregivers/site staff must not evaluate participant health or make decisions on participant's behalf. Participants with dementia or conditions that moderately/severely impair cognition are excluded (explicit exclusion). Dedicated caregiver information letters and caregiver ICFs are provided in the study documents.

Inclusion criteria

  • {"criterion_text":"- '- Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group)."}
  • {"criterion_text":"- \"- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, 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 or make decisions on behalf of the participant. Refer to Section 8 and Definition of Terms of the Clinical Study Protocol for the definition of caregiver. \""}
  • {"criterion_text":"- \"- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. \""}
  • {"criterion_text":"- '- Participants who are medically stable in the opinion of the investigator at study entry. 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.'"}

Exclusion criteria

  • {"criterion_text":"- '- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).'"}
  • {"criterion_text":"- '- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.'"}
  • {"criterion_text":"- '- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.'"}
  • {"criterion_text":"- '- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study visit, or their planned use during the study period.'"}
  • {"criterion_text":"- '- Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.'"}
  • {"criterion_text":"- '- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (For details on components of study intervention administered, refer to Arexvy SmPC/Prescribing information) [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing Information, 2023].'"}
  • {"criterion_text":"- '- Hypersensitivity to latex.'"}
  • {"criterion_text":"- '- Serious or unstable chronic illness.'"}
  • {"criterion_text":"- '- Recurrent or un-controlled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of diary cards, attend regular phone calls/study site visits).'"}
  • {"criterion_text":"- '- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.'"}
  • {"criterion_text":"- '- Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.'"}
  • {"criterion_text":"- '- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.'"}
  • {"criterion_text":"- \"- Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. \""}

Endpoints

Primary endpoints

  • {"endpoint_text":"- RSV_PreS4 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4, Day 1) and 30 days post-revaccination (Day 31) - Fold increase in RSV-A and RSV-B neutralizing titers from Day 1 to Day 31 - RSV-A and RSV-B neutralizing titers ≥cut-off at Day 1 and Day 31 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over Day 1)","definition_or_measurement_approach":"Measurement of RSV-A and RSV-B neutralizing antibody titers at specified timepoints (pre-revaccination Day 1 and Day 31) with assessment of fold increase, proportion ≥ cut-off and proportion with ≥4-fold rise."}
  • {"endpoint_text":"- \"RSV_PreS5 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4 and pre-Season 5), 30 days post-revaccination and at pre-Season 6 - Fold increase in RSV-A and RSV-B neutralizing titers from pre-Season 5 to Day 31 and pre-Season 6 - RSV-A and RSV-B neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5, Day 31 and pre-Season 6 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over pre-Season 5)\"","definition_or_measurement_approach":"Measurement of RSV-A and RSV-B neutralizing antibody titers at multiple pre- and post-revaccination timepoints (pre-Season 4/5/6 and Day 31) with calculation of fold rise and proportions meeting cut-offs and ≥4-fold increases."}

Secondary endpoints

  • {"endpoint_text":"- \"RSV_1dose group: - RSV-A and RSV-B Neutralizing titers at pre-Season 4, pre-Season 5 and pre-Season 6 - RSV-A and RSV-B Neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5 and pre-Season 6 \"","definition_or_measurement_approach":"Measurement of RSV-A and RSV-B neutralizing titers at pre-Season 4, pre-Season 5 and pre-Season 6 and assessment of proportions with titers ≥ pre-specified cut-off at those timepoints."}
  • {"endpoint_text":"- \"All participants: - Occurrence of unsolicited AEs with an onset during the 30-day follow-up period after vaccination (i.e., the day of vaccination and 29 subsequent days) - Occurrence of all SAEs/pIMDs from the day of vaccination up to 6 months after vaccination - Occurrence of SAEs/pIMDs related to study vaccination from Day 1 up to study end - Occurrence of fatal SAEs from Day 1 up to study end\"","definition_or_measurement_approach":"Safety monitoring via recording unsolicited adverse events during 30-day post-vaccination window, and recording SAEs/pIMDs up to 6 months and until study end; causality assessment for vaccine-related SAEs/pIMDs and fatal SAE recording."}

Recruitment

Planned Sample Size
7382
Recruitment Window Months
25
Consent Approach
Written or witnessed informed consent is required prior to any study-specific procedure. Caregiver letters and caregiver information/I CFs are provided and caregivers may assist participants (e.g., with diary completion) but must not make decisions or assess participant health on behalf of the participant. Multiple language informed consent documents are provided (English, French, Dutch, Italian, Estonian, Russian and others as per document list). No assent procedures (study population are adults aged 60+) were indicated.

Methods

  • Invitation letters to participants previously enrolled in the parent RSV OA=ADJ-006 study (documents titled 'Invitation letter', 'Invitation crossover', and language-specific invitation materials).
  • Site-based recruitment via participating investigational sites and primary-care / general-practitioner engagement (GP letter is listed among documents).
  • Advertising procedures referenced (document 'Advertising procedures_Redacted') and study-specific recruitment arrangements and procedures documents per country (several country-specific 'Recruitment Procedure' / 'Recruitment and Informed Consent Procedure' files).

Geography

Total Number Of Sites
96
Total Number Of Participants
7382

Belgium

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
503
Number Of Sites
11
Number Of Participants
460

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Center for Vaccinology (CEVAC)
Contact Person Name
Isabel Leroux-Roels
Contact Person Email
cevac@uzgent.be
Site Name
A.Z. Sint-Maarten
Department Name
Pneumologie
Contact Person Name
Muriel Lins
Contact Person Email
azsintmaarten@emmaus.be
Site Name
Kormont
Department Name
Huisartsen Kluisbergen
Contact Person Name
Klaas Vercruysse
Contact Person Email
info@kormont.be
Site Name
Pneumocare
Department Name
RespiSom
Contact Person Name
Jean-Benoit Martinot
Contact Person Email
martinot.j@respisom.be
Site Name
Jan Yperman Ziekenhuis
Department Name
Nephrology, Infectious Diseases & General Internal Medicine
Contact Person Name
Wim Terryn
Contact Person Email
infectieziekten@yperman.net
Site Name
Ziekenhuis Oost Limburg
Department Name
Anaesthesiology & Intensive Care
Contact Person Name
Dieter Mesotten
Contact Person Email
Dieter.mesotten@zol.be
Site Name
Anima
Department Name
ANIMA RESEARCH CENTER
Contact Person Name
Erik Buntinx
Contact Person Email
info.arc@anima-alken.be
Site Name
Dokter Lode Vermeersch Algemene Geneeskunde
Department Name
Huisartenpraktijk Dokter Lode Vermeersch
Contact Person Name
Lode Vermeersch
Contact Person Email
dokter@lodevermeersch.be
Site Name
Medif
Department Name
Cabinet Médical De Meulemeester
Contact Person Name
Marc De Meulemeester
Contact Person Email
docteur.demeu@gmail.com
Site Name
University Of Antwerp
Department Name
Center for Evaluation of Vaccination (CEV)
Contact Person Name
Ilse De Coster
Contact Person Email
ilse.decoster@uantwerpen.be
Site Name
Medisch Kabinet Dr. Guido Vereecken
Department Name
Huisartenpraktijk Dokter Guy Vereecken
Contact Person Name
Guy Vereecken
Contact Person Email
guy.vereecken@skynet.be

Estonia

Earliest CTIS Part Ii Submission Date
11-05-2024
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
516
Number Of Sites
6
Number Of Participants
429

Sites

Site Name
Aktsiaselts Medicum Tervishoiuteenused
Contact Person Name
Andres Siig
Contact Person Email
andres.siig@gmail.com
Site Name
Vee Perearstikeskus OÜ
Contact Person Name
Ingrid Alt
Contact Person Email
ingrid.alt@mail.ee
Site Name
Innomedica OÜ
Contact Person Name
Jaak Tälli
Contact Person Email
jaak.talli@innomedica.ee
Site Name
Center for Clinical and Basic Research AS
Contact Person Name
Ivo Valter
Contact Person Email
ivo.valter@nordestmedical.eu
Site Name
Tartu University Hospital
Department Name
Lung Clinic
Contact Person Name
Rain Jõgi
Contact Person Email
RainJ@kliinikum.ee
Site Name
Merelahe TK OÜ
Contact Person Name
Riin Lanno
Contact Person Email
riin.lanno@gmail.com

Finland

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
498
Number Of Sites
8
Number Of Participants
540

Sites

Site Name
FVR Suomen rokotetutkimus Oy (Järvenpää clinic)
Department Name
FVR, JÄRVENPÄÄ CLINIC
Contact Person Name
Anne Kotaniemi-Syrjänen
Site Name
FVR Suomen rokotetutkimus Oy (Helsinki)
Department Name
FVR, HELSINKI SOUTH
Contact Person Name
Ulpu Elonsalo
Site Name
FVR Suomen rokotetutkimus Oy (Oulu)
Department Name
FVR, OULU CLINIC
Contact Person Name
Satu Kokko
Contact Person Email
rokotetutkimus.oulu@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Tampere)
Department Name
FVR, TAMPERE CLINIC
Contact Person Name
Ulla Otava
Contact Person Email
rokotetutkimus.tampere@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Seinäjoki)
Department Name
FVR, SEINÄJOKI CLINIC
Contact Person Name
Hilkka Liitsola
Site Name
FVR Suomen rokotetutkimus Oy (Espoo)
Department Name
FVR, ESPOO CLINIC
Contact Person Name
Benita Ukkonen
Contact Person Email
rokotetutkimus.espoo@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Turku)
Department Name
FVR, TURKU CLINIC
Contact Person Name
Ulpu Elonsalo
Contact Person Email
rokotetutkimus.turku@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Jarvenpaa additional location)
Department Name
FVR, JÄRVENPÄÄ CLINIC (additional site entry)
Contact Person Name
Anne Kotaniemi-Syrjänen

Italy

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
512
Number Of Sites
13
Number Of Participants
80

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Dipartimento Assistenziale di Oncologia e Sanità Pubblica
Contact Person Name
Francesco Vitale
Contact Person Email
francesco.vitale@unipa.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
UOC dell'Apparato Respiratorio e Trapianto Polmonare
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@gmail.com
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
U.O.C. Medicina Interna
Contact Person Name
Raffaele Antonelli Incalzi
Contact Person Email
r.antonelli@unicampus.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Centro Medicina dell'Invecchiamento (CeMI), UOC Medicina Interna Geriatrica
Contact Person Name
Francesco Landi
Site Name
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
SSD Riabilitazione Cardiogica
Contact Person Name
Valter De Michelis
Contact Person Email
vdemichelis@ospedale.al.it
Site Name
Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti
Department Name
Dipartimento di Prevenzione Servizio Igiene e Sanità Pubblica
Contact Person Name
Sandro Cinquetti
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Unità Operativa di Pneumologia
Contact Person Name
Carlo Pomari
Contact Person Email
carlo.pomari@sacrocuore.it
Site Name
University Hospital Consorziale Policlinico
Department Name
UOC di Igiene
Contact Person Name
Silvio Tafuri
Contact Person Email
silvio.tafuri@uniba.it
Site Name
ASL To5
Department Name
SC Diabetologia Territoriale
Contact Person Name
Francesco Romeo
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Malattie Infettive
Contact Person Name
Ivan Gentile
Contact Person Email
ivan.gentile@unina.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
U.O. Igiene Ospedaliera P.O. Mater Domini
Contact Person Name
Claudia Pileggi
Contact Person Email
claudiapileggi@unicz.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
Contact Person Name
Ferdinando De Negri
Contact Person Email
f.denegri@ao-pisa.toscana.it
Site Name
University Hospital Of Ferrara
Department Name
U.O. Pneumologia
Contact Person Name
Alberto Papi
Contact Person Email
ppa@unife.it

Germany

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
505
Number Of Sites
25
Number Of Participants
1575

Poland

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
518
Number Of Sites
16
Number Of Participants
1180

Spain

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
644
Number Of Sites
17
Number Of Participants
654

Sponsor

Primary sponsor

Full Name
GlaxoSmithKline Biologicals
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
MARKEN Germany GmbH
Responsibilities
Supplies & Ancillaries
Name
Trial Form Support S.L.
Responsibilities
Data entry and study coordination support
Name
Syneos Health Inc.
Name
Sermes CRO
Responsibilities
patient fee reimbursement
Name
Fisher Clinical Services GmbH
Responsibilities
Packaging
Name
Fisher Clinical Services UK Limited
Responsibilities
Ancillaries

Third parties

  • {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Supplies & Ancillaries","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Data entry and study coordination support","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient’s travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Packaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Ancillaries","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Equipment provider","organisation_type":"Industry"}

Investigational products

Investigational Product Name
Arexvy powder and suspension for suspension for injection (Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted))
Active Substance
RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E
Modality
Vaccine
Routes Of Administration
Intramuscular use
Route
Intramuscular
Authorisation Status
Marketing authorisation present (EU/1/23/1740/001)
Frequency
Single dose (per arm descriptions)
Maximum Dose
120 µg

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