A study on the immune response and safety of vaccine against respiratory syncytial virus given to adults 18 to 49 years of age at increased risk for respiratory syncytial virus disease, compared to older adults 60 years of age and above.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]

Trial duration

4 Jun 2024 → 18 Mar 2025

Decision date (initial)

2024-05-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Part A: To demonstrate the Non-Inferiority of the humoral immune response in participants 18-49 years of age (YOA) at increased risk for RSV disease compared to older adults (OA) (≥60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.
To demonstrate the Non-Inferiority of the humoral immune response in participants 18-49 YOA at increased risk for RSV disease compared to OA (≥60 YOA) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.

Secondary objectives 2

1. Part A and B: to evaluate the safety and reactogenicity after the RSVPreF3 OA investigational vaccine administration.
2. Part A: to evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine until 6 months after study vaccination for both populations.

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. "Inclusion criteria for all participants • Participants and/or participant’s parent(s)/LAR who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications). • Written or witnessed informed consent obtained from the participant/participant’s parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure. Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age* prior to performance of any study-specific procedure. "
2. "Inclusion criteria for all participants of Cohort 1 and Cohort 3 • A male or female participant 18-49 YOA at the time of the study intervention administration. • Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator: (A stable condition is defined as a disease not requiring significant change (based on the investigator’s opinion) in therapy or worsening during the 3 months before enrollment.) • Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long‑term medication: o Chronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade 2-4 o Asthma - Patient on Maintenance and Reliever Therapy (MART) OR with at least one rescue treatment per week (excluding exercise asthma) o Cystic fibrosis o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis o Chronic heart failure - A minimum of class II symptoms according to New York Heart Association classification of heart failure o Pre-existing CAD (CAD not otherwise specified) - Physician diagnosis of CAD based on electrocardiogram, exercise stress test, nuclear stress test, cardiac computed tomography scan or cardiac angiogram (more than the presence of hypercholesterolemia) o Cardiac arrhythmia - Patient diagnosed with a cardiac arrythmia that require medical support either pharmacologically or with a medical device - Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months - Other diseases at increased risk for RSV disease o Chronic kidney disease - G2-G3 disease (Glomerular Filtration Rate between 30 and 90 ml/min/1.73 m2) o Chronic moderate to severe liver disease o Neurologic or neuromuscular conditions • Female participants of non-childbearing potential may be enrolled in the study. • Female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception from 1 month prior to study intervention administration, and - has a negative pregnancy test on the day of study prior to intervention administration, and - has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration. "
3. "Inclusion criteria for all participants of Cohort 2 A male or female participant >60 YOA at the time of the study intervention administration. • 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 medically stable by the investigator. (A stable condition is defined as a disease not requiring significant change (based on the investigator’s opinion) in therapy or worsening during the 3 months before enrollment.) • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. "

Exclusion criteria 4

1. "Exclusion criteria for all participants • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention • Unstable chronic illness. • Any history of dementia or any medical condition that moderately or severely impairs cognition. • Recurrent or uncontrolled neurological disorders or seizures. • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study."
2. "Prior/concomitant therapy/Prior/concurrent clinical study experience • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3/contact, Month 6). • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration*, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration. • Previous vaccination with any RSV vaccine, including investigational RSV vaccines • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the EOS.  Up to 3 months prior to the study intervention administration: o For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed o Administration of immunoglobulins and/or any blood products or plasma derivatives  Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. • 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 vaccine/product (drug or invasive medical device)."
3. "Other exclusions: • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. • Bedridden participants. • Planned move during the study period that will prohibit participating in the study until study end. • Participation of any study personnel or their immediate dependents, family, or household members"
4. "Other exclusions for female participants for cohort 1 and cohort 3 • Pregnant or lactating female participant. • Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration. "

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. "• RSV-A neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-A neutralizing titers from Day 1 to Day 31."
2. "• RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-B neutralizing titers from Day 1 to Day 31. "

Secondary endpoints 2

1. "• Occurrence of each solicited administration site event with onset within 4 days after dosing • Occurrence of each solicited systemic event with onset within 4 days after study intervention administration • Occurrence of unsolicited AEs within 30 days after study intervention administration • Occurrence of all SAEs (including fatal and related SAEs) and AESIs after study intervention administration (Day 1) up to study end (Month 6). "
2. "• RSV-A and RSV-B neutralizing titers, at pre-study intervention administration and 1 month and 6 months after study intervention administration. "

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 5

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications