Immunogenicity, safety, reactogenicity and persistence of an investigational respiratory syncytial virus (RSV) vaccine in adults aged 60 years and above.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

22 Feb 2021 → ongoing

Decision date (initial)

2024-06-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512291-34-00

EudraCT number

2019-004680-51

ClinicalTrials.gov

NCT04732871

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Prophylaxis, Safety

To evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.

Secondary objectives 4

1. To further evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.
2. To evaluate the humoral immune response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses, up to study end.
3. To evaluate the CMI response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses up to study end.
4. To evaluate the safety and reactogenicity of each vaccination schedule of the RSVPreF3 OA investigational vaccine in all participants.

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a LTCF (LTCF participants).
2. 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).
3. Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
4. Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients 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 by the investigator as medically stable.

Exclusion criteria 3

1. 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
2. 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
3. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.

Secondary endpoints 4

1. Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: RSVPreF3-binding Immunoglobulin G (IgG) antibody concentrations.
2. Humoral immune response at Months 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and at 1 month after each revaccination dose (Months 13, 25, 37 and 49), in a subset of participants: Neutralizing titers against RSV-A and RSV-B RSVPreF3-binding IgG antibody concentrations.
3. CMI response at pre-vaccination (Day 1), 30 days post Dose 1 (Day 31), at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and after each revaccination dose (Months 13, 25, 37, 49, 61, 66 and 72), in a subset of participants: Frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-, IFN-, IL-13, IL-17.
4. • Occurrence of each solic. admin. site + systemic event during a 4-day Fup period (i.e., on the day of vaccination and 3 subsequent days) after each vaccination. • Occurrence of any unsolic. AE during a 30-day Fup period (i.e., on the day of vaccination and 29 subsequent days) after each vaccination. • Occurrence of all SAEs and pIMDs up to 6 months after each vaccination. • Occurrence of fatal SAEs, related SAEs and related pIMDs from first vaccination (D1) up to study end (M72).

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 7

Locations

2 EU/EEA countries · 16 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

Documents 43 files

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

Application history

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