Study on the Immune Response and Safety of RSVPreF3 OA Vaccine in Adults Aged 60+ with Respiratory Syncytial Virus Infections

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What is this study about?

This clinical trial is focused on studying a disease called Respiratory Syncytial Virus (RSV) infections, which can cause respiratory illnesses, especially in older adults. The study will use a vaccine known as Arexvy, which is designed to help the body build protection against RSV. This vaccine is given as an injection and contains a special protein from the virus, combined with an ingredient that helps boost the body’s immune response.

The purpose of the study is to evaluate how well the vaccine works and how safe it is for people aged 60 and above. Participants in the study will receive the vaccine at different times to see how their immune systems respond. Some participants will receive a single dose of the vaccine, while others will receive a revaccination dose before the RSV season. The study will monitor the immune response by measuring the levels of protective substances in the blood before and after vaccination.

Throughout the study, participants will be observed for any side effects or health changes. The study will also track any serious health events that occur after vaccination. This research aims to understand the best vaccination schedule to protect older adults from RSV infections effectively.

1 joining the study

Upon joining the study, participants will be required to provide written or witnessed informed consent. This is a formal agreement to participate in the study after understanding all the procedures involved.

Participants must have been part of the previous RSV OA=ADJ-006 study and either received a placebo or a single dose of the RSVPreF3 OA vaccine.

2 initial assessment

Participants will undergo an initial assessment to ensure they are medically stable. This includes checking for chronic stable medical conditions such as diabetes, hypertension, or cardiac disease.

The investigator will determine if participants can comply with the study requirements, such as completing diary cards and attending regular phone calls or study site visits.

3 vaccination

Participants will receive a single dose of the RSVPreF3 OA vaccine, which is a vaccine against respiratory syncytial virus. The vaccine is administered as a suspension for injection through intramuscular use.

The timing of the vaccination depends on the group assignment: either before Season 4 or before Season 5.

4 follow-up period

After vaccination, participants will be monitored for a 30-day follow-up period. During this time, any unsolicited adverse events (AEs) will be recorded.

Participants will also be monitored for serious adverse events (SAEs) and potential immune-mediated diseases (pIMDs) from the day of vaccination up to six months after vaccination.

5 immunogenicity assessment

The study will evaluate the immune response by measuring RSV-A and RSV-B neutralizing titers before and after vaccination. This involves checking the levels of antibodies that can neutralize the virus.

For the RSV_PreS4 group, this assessment occurs before revaccination and 30 days post-revaccination. For the RSV_PreS5 group, it includes additional assessments at pre-Season 5 and pre-Season 6.

6 study completion

The study is estimated to end by September 30, 2026. Participants will continue to be monitored for any SAEs or pIMDs related to the study vaccination until the study concludes.

Participants will be informed of the study results and any relevant findings related to their health.

Who Can Join the Study?

  • Participants must be male or female who were previously part of the RSV OA=ADJ-006 study and received either a placebo (a harmless pill or injection with no active medicine) or a single dose of the RSVPreF3 OA vaccine.
  • Participants should be able to follow the study requirements, such as filling out diary cards, attending regular phone calls or study site visits, and using a phone or other electronic communication devices. If a participant cannot fill out the diary cards due to physical limitations, they can have help from site staff or a caregiver, but these helpers cannot make health decisions for the participant.
  • Participants must provide written or witnessed informed consent before any study-specific procedures are performed. This means they agree to participate after understanding the study details.
  • Participants should be medically stable at the start of the study, as judged by the investigator. This means their health condition is not changing rapidly. Participants with ongoing stable medical conditions, like diabetes, high blood pressure, or heart disease, can join the study.

Who Cannot Join the Study?

  • Patients who have a known allergy to any component of the vaccine cannot participate.
  • Individuals with a history of severe allergic reactions, also known as anaphylaxis, to any vaccine are excluded. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
  • Participants who have received any other vaccine within 30 days prior to the study start date are not eligible.
  • People with a weakened immune system, which means their body has a reduced ability to fight infections, cannot take part in the study.
  • Individuals currently participating in another clinical trial are not allowed to join this study.
  • Pregnant or breastfeeding women are excluded from participating in the trial.
  • Anyone with a current or recent respiratory illness, which affects the lungs and breathing, is not eligible.
  • Participants with any condition that, in the opinion of the study doctor, might interfere with the results of the study or the safety of the participant are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Praxis Dr. med. Andreas Preusche Dippoldiswalde Germany
Praxis Kerstin Steinbach Freital Germany
Kormont Kluisbergen Belgium
Berliner Centrum Fur Reise Und Tropenmedizin GmbH Berlin Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Fundacion De Oftalmologia Medica De La Comunitat Valenciana Valencia Spain
Futuremeds Sp. z o.o. Wroclaw Poland
Al Mare Perearstikeskus OU Tallin Estonia
Innomedica OÜ Tallin Estonia
Vee Perearstikeskus OÜ Paide Estonia

Other Sites

Site Name City Country Status
Studienzentrum Dr. Faulmann GbR Dresden Germany
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
Medizentrum Essen Borbeck Essen Germany
Silmedic Sp. z o.o. Katowice Poland
Pneumocare Namur Belgium
Medif Thuin Belgium
medicoKIT GmbH Goch Germany
SGS proderm GmbH Schenefeld Germany
Pro Familia Altera Sp. z o.o. Katowice Poland
Equip D’assistencia Primaria Vic S.L.P. Vic Spain
Studienpraxis Heimeranplatz Munich Germany
Universita’ Campus Bio-medico Di Roma Rome Italy
Tartu University Hospital Tartu Estonia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Eurofins bioskin GmbH Hamburg Germany
Synexus Polska Sp. z o.o. Poznan Poland
Jan Yperman Ziekenhuis Ieper Belgium
KliFoCenter GmbH Witten Germany
Ziekenhuis Oost Limburg Genk Belgium
Equip D’atencio Primaria Barcelona Sardenya S.L.P. Barcelona Spain
Anima Alken Belgium
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Consorci D’atencio Primaria De Salut Barcelona Esquerra Barcelona Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
University Hospital Consorziale Policlinico Bari Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Zentrum für klinische Forschung Allgäu Oberschwaben Wangen Germany
Center for Clinical and Basic Research AS Tallin Estonia
Aktsiaselts Medicum Tervishoiuteenused Tallin Estonia
Medizinisches Versorgungszentrum Dachau Dachau Germany
Gemeinschaftspraxis Drs. Grosskopf Wallerfing Germany
Velocity Clinical Research Hamburg GmbH Hamburg Germany
Praxis Dr. med. Michael Müller Freiberg Germany
Hyzjsfvg Uipbjzzgrtuiu Dn Lm Prkuznaz Madrid Spain
Ebpsgvr Mechelen Belgium
Uip Kgxvmaqph Faezxljzo Essen Germany
Dlxsab Lbqa Vvskwimotu Awilwdkf Glqzejklqwk Tremelo Belgium
Aopwgof Uposj Lhpgio Srhzl Sktfsvpiz Np 1 Djfybdbb Belluno Italy
Pwntby Dck Jsjitl Sihxvfl Hochheim Am Main Germany
Mvzbmlqo Gcjd Weinheim Germany
Mlgpw Tsiqri Sd Us (lfgbbzenndpzmegsjtgy Berlin Germany
Pyhimwqmx Sblfvnpoo I Szlvdik Sgur Barcelona Spain
Uihedmaqbz Os Aknxonl Edegem Belgium
Agw Tpl Chieri Italy
Cbu Vdirelkh Barcelona Spain
Anupods Opsfjrynksh Uunnyvmdfuhfw Sffysl Siena Italy
Awtffki Oekffnpsdni Nmofjrxgc St Aejfwub E Binhlm E C Amzqda Apcoreenqcw Alexandria Italy
Ujaoarqoxv Mtawx Gqzjcwu On Cnzaeoydn Catanzaro Italy
Fopahuqnp Pipo Lj Ixtuaoynizniw Bkihgaowa Dyy Hrbfzwwy Uyqdefphnuenr Lk Phe Madrid Spain
Zozxeej ffu kbvjpcbbw Fudyqvoib Cologne Germany
Ckdmuow Buqhl Kpaibnqtqqg Azzgserta Mfsqa Elblag Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.08.2024
Estonia Estonia
Not recruiting
01.08.2024
Finland Finland
Not recruiting
01.08.2024
Germany Germany
Not recruiting
01.08.2024
Italy Italy
Not recruiting
01.08.2024
Poland Poland
Not recruiting
01.08.2024
Spain Spain
Not recruiting
01.08.2024

Trial locations

RSVPreF3 OA vaccine is a vaccine designed to protect against respiratory syncytial virus (RSV) in older adults. This vaccine works by stimulating the body’s immune system to produce antibodies that can fight off the virus if the person is exposed to it in the future. In this clinical trial, the vaccine is being tested to see how well it works when given as a single revaccination dose before the RSV season, and to check how long the protection lasts in adults aged 60 years and above.

Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus is highly contagious and spreads through droplets from coughs or sneezes. Infections often begin with symptoms similar to a common cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in infants and older adults, such as bronchiolitis or pneumonia. The virus can cause inflammation and obstruction of the small airways in the lungs, leading to difficulty breathing. Recovery from the infection can take several weeks, with symptoms gradually improving over time.

Trial ID:
2023-509762-38-00
Protocol code:
222090
Trial Phase:
Therapeutic confirmatory (Phase III)

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