A Phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety, and reactogenicity of respiratory syncytial virus (RSV) prefusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in adults aged 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] - Virus Diseases [C02]

Trial duration

17 Aug 2023 → 8 May 2024

Decision date (initial)

2023-07-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Biologicals S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

• To demonstrate the non-inferiority of PCV20 when co‑administered with the RSVPreF3 OA investigational vaccine compared to PCV20 administered alone;
• To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine in terms on RSV-A neutralization antibodies when co administered with PCV20 compared to RSVPreF3 OA investigational vaccine administered alone;
• To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine in terms of RSV-B neutralization antibodies when co administered with the PCV20 vaccine compared to RSVPreF3 OA investigational vaccine administered alone.

Secondary objectives 2

1. • To evaluate the humoral immune response to RSVPreF3 OA investigational vaccine when co administered with the PCV20 or administered alone;
2. • To evaluate the safety and reactogenicity following administration of the RSVPreF3 OA investigational vaccine and PCV20, co-administered or administered alone.

Conditions and MedDRA coding

RSV-associated (subtypes A and B) disease in adults aged 60 years of age and older.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. • A male or female ≥60 YOA at the time of the first study intervention administration.
2. • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications). o Note: In case of physical incapacity that would preclude the self-completion of the eDiary, 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 will the site staff or caregiver* evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. *A ‘caregiver’ is a person who has a continuous caring role for a participant or may be a person having substantial periods of contact with a participant and/or is engaged in his/her daily health care (e.g., a relative of the participant including family members or friends).
3. • Written or witnessed informed consent obtained from the participant prior to any study-specific procedure being performed.
4. • 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.
5. • Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion criteria 20

1. • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
2. • History of any reaction or hypersensitivity (e.g., anaphylaxis) likely to be exacerbated by the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or PPSV23.
3. • Participants considered by investigator as suffering from serious or unstable chronic illness.
4. • Any history of dementia or any medical condition that moderately or severely impairs cognition.
5. • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled 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.
6. • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
7. • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
8. • History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation.
9. • History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation.
10. • Previous vaccination with any licensed or investigational RSV vaccine
11. • Use of any investigational or non-registered product (drug, vaccine or 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 study intervention administration, or their planned use during the study period.
12. • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. o Planned or actual administration of adjuvanted quadrivalent influenza vaccine or live influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
13. • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
14. • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period.
15. • 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 first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
16. •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).
17. • 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.
18. • Bedridden participants.
19. • Planned move during the study conduct that prohibits participation until study end.
20. • Participation of any study personnel or their immediate dependents, family, or household members.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. • Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST) expressed as between groups geometric mean titer (GMT) ratio, 1 month after the PCV20 dose.
2. • RSV-A neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose.
3. • RSV-B neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose.

Secondary endpoints 6

1. • RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose.
2. • RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose.
3. • Percentage of participants reporting each solicited event with onset within 7 days after vaccine administration (i.e., the day of vaccination and 6 subsequent days)
4. • Percentage of participants reporting unsolicited AE within 30 days after vaccine administration (i.e., the day of vaccination and 29 subsequent days)
5. • Percentage of participants reporting SAEs after vaccine administration (Day 1) up to EoS (6 months after last vaccination).
6. • Percentage of participants reporting pIMDs after vaccine administration (Day 1) up to EoS (6 months after last vaccination).

Investigational products

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

Test 1

Auxiliary 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

3 EU/EEA countries · 27 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 14 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