A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

Last updated: August 9, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RSVPreF3 OA investigational vaccine

Placebo

Clinical Study ID

NCT06551181
219815
2023-509455-13-00
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult male or female of ≥60 YOA at the time of study intervention administration,who live in the community dwelling (CD participants).

  • Participants who, in the opinion of the investigator, can and will comply with therequirements of the protocol (e.g., completion of the diary cards, attend regularphone calls/study site visits, perform self-swabbing (study participants in Chinaonly), ability to access and utilize a phone or other electronic communications).

  • Participants who are medically stable in the opinion of the investigator at the timeof vaccination. Participants with chronic stable medical conditions with or withoutspecific treatment, such as diabetes, hypertension or cardiac disease, are allowedto participate in this study if considered by the investigator as medically stable.

  • Written or witnessed informed consent obtained from the participant (participantmust be able to understand the informed consent) prior to performance of any studyspecific procedure.

Exclusion

Exclusion Criteria:

Medical Conditions:

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study intervention(s).

  • Any clinical conditions for which serum samples would be prohibited for transfer tolocal central lab for testing. These clinical conditions include hepatitis B,hepatitis C, HIV and Syphilis based on medical history and physical examination (allparticipants) and laboratory screening tests (overseas participants).

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resultingfrom disease (e.g., current malignancy, human immunodeficiency virus) orimmunosuppressive/cytotoxic therapy (e.g., medication used during cancerchemotherapy, organ transplantation, or to treat autoimmune disorders), based onmedical history and physical examination (no laboratory testing required).

  • Any history of dementia or any medical condition that moderately or severely impairscognition.

  • Recurrent history or uncontrolled neurological disorders or seizures. Participantswith medically controlled active or chronic neurological diseases can be enrolled inthe study as per investigator assessment, provided that their condition will allowthem to comply with the requirements of the protocol (e.g. completion of the diarycards, attend regular phone calls/study site visits, perform self-swabbing (studyparticipants in China only).

  • Significant underlying illness that in the opinion of the investigator would beexpected to prevent completion of the study (e.g., life-threatening disease likelyto limit survival to less than 1 year).

  • Serious or unstable chronic illness.

  • Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.

Prior/Concomitant Therapy:

  • Previous vaccination with RSV vaccine.

  • Use of any investigational or non-registered product (drug, vaccine or invasivemedical device) other than the study intervention(s) during the period beginning 30days before the dose of study intervention(s), or their planned use during the studyperiod.

  • Planned or actual administration of a vaccine not foreseen by the study protocol inthe period starting 30 days before and ending 30 days after study interventionadministration, with the exception of COVID-19 and inactivated/subunit influenzavaccines which can be administered up to 14 days before or from 14 days after eachstudy intervention.

  • Administration of long-acting immune-modifying drugs or planned administration atany time during the study period (e.g., infliximab).

  • Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 90 days before the study intervention administration orplanned administration during the study period.

  • Chronic administration (defined as more than 14 consecutive days in total) ofimmunosuppressants or other immune-modifying drugs during the period starting 90days prior to the study intervention administration or planned administration duringthe study period. For corticosteroids, this will mean prednisone >=20 mg/day, orequivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent Clinical Study Experience:

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).

Other Exclusion Criteria:

  • History of chronic alcohol consumption and/or drug abuse as deemed by theinvestigator to render the potential participant unable/unlikely to provide accuratesafety reports or comply with study procedures.

  • Bedridden participants.

  • Planned move during the study conduct that prohibits participation until study end.

  • Participation of any study personnel or their immediate dependents, family, orhousehold members.

Study Design

Total Participants: 2600
Treatment Group(s): 2
Primary Treatment: RSVPreF3 OA investigational vaccine
Phase: 3
Study Start date:
August 05, 2024
Estimated Completion Date:
September 12, 2025

Connect with a study center

  • GSK Investigational Site

    Shanghai, 201620
    China

    Site Not Available

  • GSK Investigational Site

    Espoo, 02230
    Finland

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00290
    Finland

    Site Not Available

  • GSK Investigational Site

    Kokkola, 67100
    Finland

    Site Not Available

  • GSK Investigational Site

    Oulu, 90220
    Finland

    Site Not Available

  • GSK Investigational Site

    Seinajoki, 60100
    Finland

    Site Not Available

  • GSK Investigational Site

    Tampere, 33100
    Finland

    Site Not Available

  • GSK Investigational Site

    Turku, 20520
    Finland

    Site Not Available

  • GSK Investigational Site

    Tokyo, 160-0017
    Japan

    Site Not Available

  • GSK Investigational Site

    Guri-si, 471-701
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Incheon, 400-711
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 152-703
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Elblag, 82-300
    Poland

    Site Not Available

  • GSK Investigational Site

    Katowice, 40-600
    Poland

    Site Not Available

  • GSK Investigational Site

    Krakow, 31-501
    Poland

    Site Not Available

  • GSK Investigational Site

    Lodz, 91-363
    Poland

    Site Not Available

  • GSK Investigational Site

    Lublin, 20-362
    Poland

    Site Not Available

  • GSK Investigational Site

    Sochaczew, 96-500
    Poland

    Site Not Available

  • GSK Investigational Site

    Warszawa, 00-215
    Poland

    Site Not Available

  • GSK Investigational Site

    Wroclaw, 50-088
    Poland

    Site Not Available

  • GSK Investigational Site

    Avila, 05071
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Burgos, 09006
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Site Not Available

  • GSK Investigational Site

    Valladolid, 47003
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Belfast, BT7 2EB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Blackpool, FY3 7EN
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Bristol, BS37 4AX
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cambridgeshire, CB7 5JD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Eynsham, OX29 4QB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Hounslow, TW3 3EL
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Witney, OX28 6JS
    United Kingdom

    Site Not Available

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