A study on the immune response, safety and the occurrence of RSV-associated respiratory tract illness after administration of RSV OA vaccine in adults 60 years and older.

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

Trial duration

5 Aug 2024 → 28 Nov 2025

Decision date (initial)

2024-07-24

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: Safety, Others

• To demonstrate the non-inferiority (NI) of humoral immune response in Chinese older adults (OA) enrolled in the RSV OA group (China) compared to OA enrolled in the RSV OA group (Overseas), for the RSV-A strain after the RSVPreF3 OA investigational vaccine administration.
• To demonstrate the NI of humoral immune response in Chinese OA enrolled in the RSV OA group (China), compared to OA enrolled in the RSV OA group (Overseas), for the RSV-B strain after the RSVPreF3 OA investigational vaccine administration.

Secondary objectives 4

1. To evaluate the humoral immune response in Chinese OA enrolled in the RSV OA group (China) compared to OA enrolled in the RSV OA group (Overseas), up to 6 months post vaccination.
2. To evaluate the humoral immune response in Chinese OA enrolled in the RSV OA group (China) compared to historical data generated in the immunogenicity subset of the global efficacy study RSV OA=ADJ-006.
3. To describe the RSV-confirmed acute respiratory illness and RSV-confirmed lower respiratory tract disease in RSV OA Vaccine group (China) and Placebo group (China).
4. To evaluate the safety and reactogenicity following the administration of the investigational RSVPreF3 OA vaccine.

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants) (see definition of terms for the definition). INC#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, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications). INC#2 Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. • Participants who are medically stable in the opinion of the investigator at the time of 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#3 • 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#4

Exclusion criteria 2

1. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) (For details on components of study intervention administered, refer to Table 9 and Arexvy [Summary of Product Characteristics, 2023; Prescribing Information, 2023]. EXC#1 • Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants). EXC#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#3 • Any history of dementia or any medical condition that moderately or severely impairs cognition. EXC#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 the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only). EXC#5 • 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 to less than 1 year). EXC#6 • Serious or unstable chronic illness. EXC#7 • 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#8 • Previous vaccination with RSV vaccine. EXC#9 • Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period. EXC#10
2. • 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 study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention. EXC#11 Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g., infliximab). EXC#12 • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period. EXC#13 • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed. EXC#14 • 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). Refer to Definition of Terms for the definition of invasive medical device. EXC#15 • 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#16 • Bedridden participants. EXC#17 • Planned move during the study conduct that prohibits participation until study end. EXC#18 • Participation of any study personnel or their immediate dependents, family, or household members. EXC#19

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. • RSV-A neutralization titres expressed as group GMT ratio (RSV OA group [Overseas] / RSV OA group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration. • RSV-A neutralization titres expressed as group seroresponse rate (SRR) difference (RSV OA group [Overseas] - RSV OA group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration.
2. • RSV-B neutralization titres expressed as group GMT ratio (RSV OA group [Overseas] / RSV OA group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration. • RSV-B neutralization titres expressed as group SRR difference (RSV OA group [Overseas] - RSV OA group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration.

Secondary endpoints 9

1. • RSV-A and RSV-B neutralization titres expressed as GMT, at baseline, 1 month and 6 months after the RSVPreF3 OA investigational vaccine administration. • RSV-A and RSV-B neutralization titers expressed as SRR, 1 month and 6 months after the RSVPreF3 OA investigational vaccine administration.
2. • RSV-A and RSV-B neutralization titres expressed as group GMT ratio (RSV OA=ADJ-006 / RSV OA Vaccine group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration. • RSV-A and RSV-B neutralization titres expressed as group SRR difference (RSV OA=ADJ-006 - RSV OA Vaccine group [China]), 1 month after the RSVPreF3 OA investigational vaccine administration.
3. Occurrence of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD, according to the case definition. In study participants in China with RT-PCR-confirmed RSV A and/or B associated ARI and LRTD cases: • Duration of episodes. • Reported symptoms/signs. • ARI/LRTD severity. • Frailty status.
4. For RSV OA group (China) and Placebo group (China): • Percentage of participants reporting each solicited administration site event with onset within 7 days after study intervention administration (i.e., the day of study intervention administration and 6 subsequent days). • Percentage of participants reporting each solicited systemic event with onset within 7 days after study intervention administration (i.e., the day of study intervention administration and 6 subsequent days).
5. For RSV OA group (China) and Placebo group (China): • Percentage of participants reporting unsolicited AEs within 30 days after study intervention administration (i.e., the day of study intervention administration and 29 subsequent days). • Percentage of participants reporting SAEs after study intervention administration (Day 1) up to 6 months after study intervention.
6. For RSV OA group (China) and Placebo group (China): • Percentage of participants reporting pIMDs after study intervention administration (Day 1) up to 6 months after study intervention. • Percentage of participants reporting SAEs related to study intervention after study intervention administration (Day 1) up to study end. • Percentage of participants reporting pIMDs related to study intervention after study intervention administration (Day 1) up to study end.
7. For RSV OA group (China) and Placebo group (China): • Percentage of participants reporting any fatal SAEs after study intervention administration (Day 1) up to study end.
8. For RSV OA group (Overseas): • Percentage of participants reporting SAEs after study intervention administration (Day 1) up to study end (Month 6). • Percentage of participants reporting pIMDs after study intervention administration (Day 1) up to study end (Month 6). • Percentage of participants reporting SAEs related to study intervention after study intervention administration (Day 1) up to study end (Month 6).
9. For RSV OA group (Overseas): • Percentage of participants reporting pIMDs related to study intervention after study intervention administration (Day 1) up to study end (Month 6). • Percentage of participants reporting any fatal SAEs after study intervention administration (Day 1) up to study end (Month 6).

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 13

Locations

3 EU/EEA countries · 22 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 16 files

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

Application history

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