A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

Last updated: October 3, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RSVPreF3 OA investigational vaccine

Placebo

Clinical Study ID

NCT06614725
221265
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

• Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.

Specific inclusion criteria for all participants in Cohort 1 (Older adults)

  • Male or female, >= 60 YOA at the time of the study intervention administration.

  • Participants who are medically stable in the opinion of the investigator at the timeof study intervention administration. Participants with chronic stable medicalconditions with or without specific treatment, such as diabetes mellitus,hypertension, or cardiac disease, are allowed to participate in this study ifconsidered by the investigator as medically stable.

  • Participants living in the general community or in an assisted-living facility thatprovides minimal assistance can be enrolled, such that the participant is primarilyresponsible for self-care and activities of daily living.

Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR)

  • Male or female, 50-59 YOA at the time of the study intervention administration.

  • Participants should be diagnosed with at least 1 of the following medical conditionsand considered medically stable by the investigator:

  • Chronic pulmonary disease resulting in activity restricting symptoms or use of longterm medication:

  • Chronic obstructive pulmonary disease (COPD)

  • Asthma

  • Cystic fibrosis

  • Other chronic respiratory diseases: lung fibrosis, restrictive lung disease,interstitial lung disease, emphysema, or bronchiectasis

  • Chronic cardiovascular disease:

  • Chronic heart failure (CHF)

  • Pre-existing coronary artery disease (CAD not otherwise specified)

  • Cardiac arrhythmia

  • Diabetes mellitus: type 1 or type 2

Other diseases at increased risk for RSV-LRTD disease:

  • Chronic kidney disease

  • Chronic liver disease

  • Female participants of non-childbearing potential may be enrolled in the study.Non childbearing potential is defined as hysterectomy, bilateral oophorectomy,bilateral salpingectomy, or post-menopause.

  • Female participants of childbearing potential may be enrolled in the study ifthe participant

  • has practiced adequate contraception from 1 month prior to study interventionadministration, and

  • has a negative pregnancy test on the day of and prior to study interventionadministration, and

  • has agreed to continue adequate contraception for at least 1 month after the studyintervention administration.

Exclusion

Exclusion Criteria:

Medical Conditions

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions.

  • 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).

  • Unstable chronic illness.

  • 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 eDiary,attend phone call/study site visits).

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

  • Significant underlying illness that in the opinion of the investigator would beexpected to prevent completion of the study (e.g., life-threatening disease).

  • Any medical condition that in the judgment of the investigator would makeintramuscular injection unsafe.

  • 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

  • Use of any investigational or non-registered product (drug, vaccine or invasivemedical device) other than the study interventions during the period beginning 30days (Day -29 to Day 1) before the dose of study interventions or their planned useduring the study period (Day 1 up to Month 6).

  • Previous vaccination with licensed or investigational RSV vaccine. Planned or actualadministration of a vaccine not foreseen by the study protocol in the periodstarting 30 days before and ending 30 days after the dose of study interventionadministration, with the exception of inactivated, subunit and split influenzavaccines or COVID-19 vaccines (fully licensed or with emergency use authorization [EUA]) which can be administered up to 14 days before or from 14 days after thestudy intervention administration.

  • Chronic administration of immune-modifying drugs (defined as more than 14consecutive days in total) and/or planned use of long-acting immune-modifyingtreatments at any time up to the end of the study.

  • Up to 3 months prior to the study intervention administration:

  • For corticosteroids, this will mean prednisone equivalent >= 20 mg/day foradult participants. Inhaled and topical steroids are allowed.

  • Administration of immunoglobulins and/or any blood products or plasmaderivatives.

  • Up to 6 months prior to study intervention administration: long-acting immunemodifying drugs including among others immunotherapy (e.g., TNF-inhibitors),monoclonal antibodies, antitumoral medication.

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 for all participants

  • 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.

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

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

  • Bedridden participants.

Other Exclusion Criteria for cohort 2 (Adults-AIR)

  • Pregnant or lactating female participant.

  • Female participant planning to become pregnant or planning to discontinuecontraceptive precautions.

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: RSVPreF3 OA investigational vaccine
Phase: 3
Study Start date:
October 01, 2024
Estimated Completion Date:
October 28, 2025

Connect with a study center

  • GSK Investigational Site

    Ahmedabad, 380015
    India

    Active - Recruiting

  • GSK Investigational Site

    Aligarh, 202002
    India

    Active - Recruiting

  • GSK Investigational Site

    Bangalore, 560002
    India

    Active - Recruiting

  • GSK Investigational Site

    Belagavi, 590019
    India

    Active - Recruiting

  • GSK Investigational Site

    Darjeeling, 734012
    India

    Active - Recruiting

  • GSK Investigational Site

    Delhi, 110060
    India

    Active - Recruiting

  • GSK Investigational Site

    Kanpur, 208002
    India

    Active - Recruiting

  • GSK Investigational Site

    Kelambakkam, 603103
    India

    Active - Recruiting

  • GSK Investigational Site

    Kochi, 682026
    India

    Active - Recruiting

  • GSK Investigational Site

    Kolkata, 700073
    India

    Active - Recruiting

  • GSK Investigational Site

    Mandya, 571401
    India

    Site Not Available

  • GSK Investigational Site

    Mangalore, 575003
    India

    Site Not Available

  • GSK Investigational Site

    Nehru Nagar Belagavi Karnataka 590010, 590010
    India

    Site Not Available

  • GSK Investigational Site

    Pune-411 043, 411043
    India

    Active - Recruiting

  • GSK Investigational Site

    Raipur,
    India

    Active - Recruiting

  • GSK Investigational Site

    Srikakulam, 532001
    India

    Active - Recruiting

  • GSK Investigational Site

    Vadu Budruk Pune, 412216
    India

    Active - Recruiting

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