A study on the immune response and safety of a vaccine against respiratory syncytial virus (RSV) when given alone and together with a vaccine against SARS-CoV-2 in adults aged 50 years and above.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

15 Jun 2024 → 19 Apr 2025

Decision date (initial)

2024-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

• To demonstrate non-inferiority of humoral immune response to RSVPreF3 OA investigational vaccine when co-administered with a COVID 19 mRNA vaccine compared to RSVPreF3 OA investigational vaccine administered alone.
• To demonstrate non-inferiority of humoral immune response to a COVID-19 mRNA vaccine when co-administered with the RSVPreF3 OA investigational vaccine compared to COVID-19 mRNA vaccine administered alone.

Secondary objectives 3

1. To evaluate the humoral immune response to RSVPreF3 OA investigational vaccine when co-administered with a COVID-19 mRNA vaccine or administered alone.
2. To evaluate the humoral immune response to a COVID-19 mRNA vaccine when co-administered with the RSVPreF3 OA investigational vaccine or administered alone.
3. To evaluate the safety and reactogenicity following administration of the RSVPreF3 OA investigational vaccine and a COVID-19 mRNA vaccine, co-administered or administered alone.

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 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, return for follow-up visits). INC#1
2. 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. INC#2
3. A male/female of ≥50 YOA at the time of the first study intervention administration. INC#3
4. Participants who are medically stable in the opinion of the investigator at the time of first vaccination. 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 by the investigator as medically stable. INC#4
5. 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. INC#5
6. Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination. INC#6
7. Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause. INC#7
8. "Female participants of childbearing potential may be enrolled in the study if the participant. INC#8  has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception for at least 1 month after the last vaccination.  has a negative pregnancy test on the day of and prior to study intervention administration. "

Exclusion criteria 23

1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g., anaphylaxis). EXC#1
2. 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 (no laboratory testing required). EXC#2
3. Any history of myocarditis or pericarditis. EXC#3
4. Recurrent history or uncontrolled 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 (e.g. completion of diary cards, attend regular phone calls/study site visits). EXC#4
5. Serious or unstable chronic illness. EXC#5
6. Any history of dementia or any medical condition that moderately or severely impairs cognition. EXC#6
7. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end). EXC#7
8. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. EXC#8
9. Any SAE attributed to a previous dose of the SARS-CoV-2 mRNA vaccine. EXC#9
10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. EXC#10
11. Recent SARS-CoV-2 infection within 3 months prior to the COVID-19 vaccine dose administration. Timelines to be determined from symptoms onset or positive COVID-19 test (if infection was asymptomatic). EXC#11
12. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last vaccine administration, or their planned use during the study period. EXC#12
13. Planned administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination. EXC#13
14. "• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the last blood sampling visit. EXC#14  Up to 3 months prior to the study intervention administration: o For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical 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 and antitumoral medication."
15. Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study COVID-19 mRNA vaccine administration. EXC#15
16. Previous vaccination with licensed or investigational RSV vaccine. EXC#16
17. 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). EXC#17
18. Pregnant or lactating female participant. EXC#18
19. Female participant planning to become pregnant or planning to discontinue contraceptive precautions. EXC#19
20. 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. EXC#20
21. Participation of any study personnel or their immediate dependents, family, or household members. EXC#21
22. Planned move during the study conduct that prohibits participation until study end. EXC#22
23. Bedridden participants. EXC#23

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. • RSV-A neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose. • RSV-B neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose.
2. • SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein expressed as group GMT ratio 1 month after the COVID-19 mRNA vaccine.

Secondary endpoints 4

1. • RSV-A and RSV-B neutralization titers expressed as GMT, MGI and SRR at 1 month after the RSVPreF3 OA investigational vaccine dose. • Percentage of participants having RSV-A and RSV-B neutralizing titers ≥ assay cut-off (i.e., LLOQ) at pre-vaccination and 1 month after the RSVPreF3 OA investigational vaccine dose.
2. "• SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein expressed as GMT and MGI at 1 month after the COVID-19 mRNA vaccine. • Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers ≥ assay cut-off (i.e., LLOQ) at pre-vaccination and 1 month after the COVID-19 mRNA vaccine dose."
3. "• Percentage of participants reporting each solicited administration site event and systemic event within 4 days post study intervention administration (i.e., the day of vaccination and 3 subsequent days). • Percentage of participants reporting unsolicited AEs within 30 days post study intervention administration (i.e., the day of vaccination and 29 subsequent days)."
4. "• Percentage of participants reporting SAEs after study intervention administration (Day 1) up to study end (6 months after last study intervention administration). • Percentage of participants reporting pIMDs after study intervention administration (Day 1) up to study end (6 months after last study intervention administration). "

Investigational products

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

Test 1

Comparator 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 14

Locations

3 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 30 files

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

Application history

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