A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above.

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05559476

Collaborator

(none)

1,028

Enrollment

Locations

Arms

9.7

Anticipated Duration (Months)

21.9

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSVPreF3 OA investigational vaccine Biological: FLU HD vaccine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1028 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above.

Actual Study Start Date :

Oct 20, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Aug 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Co-Ad Group Participants randomized to Co-Ad Group receive 1 dose of RSVPreF3 OA investigational vaccine and 1 dose of FLU HD at Day 1 and are followed up until the study end.	Biological: RSVPreF3 OA investigational vaccine RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Biological: FLU HD vaccine FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).
Active Comparator: Control Group Participants randomized to Control Group receive 1 dose of FLU HD at Day 1, followed by 1 dose of RSVPreF3 OA investigational vaccine at Day 31 and are followed up until the study end.	Biological: RSVPreF3 OA investigational vaccine RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Biological: FLU HD vaccine FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Arm

Intervention/Treatment

Experimental: Co-Ad Group

Participants randomized to Co-Ad Group receive 1 dose of RSVPreF3 OA investigational vaccine and 1 dose of FLU HD at Day 1 and are followed up until the study end.

Biological: RSVPreF3 OA investigational vaccine

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: FLU HD vaccine

FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Active Comparator: Control Group

Participants randomized to Control Group receive 1 dose of FLU HD at Day 1, followed by 1 dose of RSVPreF3 OA investigational vaccine at Day 31 and are followed up until the study end.

Biological: RSVPreF3 OA investigational vaccine

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: FLU HD vaccine

FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Outcome Measures

Primary Outcome Measures

RSV-A neutralization antibody titers expressed as group geometric mean titer (GMT) ratio [1 month after the RSVPreF3 OA investigational vaccine dose]
Hemagglutinin inhibition (HI) antibody titers for each of the FLU vaccine strains, expressed as group GMT ratio [1 month after the FLU vaccine dose]

Secondary Outcome Measures

HI seroconversion rate (SCR) for each of the FLU vaccine strains [1 month after the FLU vaccine dose]
RSV-A neutralization antibody titers expressed as mean geometric increase (MGI) [1 month after the RSVPreF3 OA investigational vaccine dose]
RSV-B neutralization antibody titers expressed as group GMT ratio [1 month after the RSVPreF3 OA investigational vaccine dose]
RSV-B neutralization antibody titers expressed as MGI [1 month after the RSVPreF3 OA investigational vaccine dose]
HI antibody titers for each of the FLU vaccine strains, expressed as GMT [At Day 1 and 1 month after vaccination (Day 31)]
HI seroprotection rate (SPR) for each of the FLU vaccine strains [At Day 1 and 1 month after vaccination (Day 31)]
HI antibody titers for each of the FLU vaccine strains, expressed as MGI [1 month after the FLU vaccine dose]
Percentage of participants with solicited administration site events [Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)]
The solicited administration site events after vaccination include pain, erythema/redness and swelling.
Percentage of participants with solicited systemic events [Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)]
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Percentage of participants with unsolicited adverse events (AEs) (potential immune-mediated disease (pIMD), non-serious AE or serious AE) [Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination]
An unsolicited AEs is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious, non-serious AEs and pIMDs.
Percentage of participants with serious adverse events (SAEs) [From Day 1 up to study end (6 months after last vaccination)]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Percentage of participants with pIMDs [From Day 1 up to study end (6 months after last vaccination)]
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
A male or female ≥65 years of age at the time of the first study intervention administration.
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.
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
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 are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria:

Medical conditions

Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of Guillain Barré syndrome, or anaphylaxis.
Serious or unstable chronic illness.
Any history of dementia or any medical condition that moderately or severely impairs cognition.
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 (e.g. completion of diary cards, attend regular phone calls/study site visits).
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

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 study vaccine administration, or planned use during the study period.
Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration.
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.

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.

Previous vaccination with an RSV vaccine.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period.
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 vaccination or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

• 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).

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.
Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.
Bedridden participants.
Participation of any study personnel or their immediate dependents, family, or household members.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35205
2	GSK Investigational Site	Tempe	Arizona	United States	85281
3	GSK Investigational Site	Canoga Park	California	United States	91303
4	GSK Investigational Site	Colton	California	United States	92324
5	GSK Investigational Site	Sacramento	California	United States	95864
6	GSK Investigational Site	San Diego	California	United States	92103-6204
7	GSK Investigational Site	Walnut Creek	California	United States	94598
8	GSK Investigational Site	Aurora	Colorado	United States	80012
9	GSK Investigational Site	Coral Gables	Florida	United States	33134
10	GSK Investigational Site	Fort Myers	Florida	United States	33912
11	GSK Investigational Site	Hialeah	Florida	United States	33012
12	GSK Investigational Site	Immokalee	Florida	United States	34142
13	GSK Investigational Site	Miami	Florida	United States	33016
14	GSK Investigational Site	Miami	Florida	United States	33184
15	GSK Investigational Site	Orlando	Florida	United States	32801
16	GSK Investigational Site	West Palm Beach	Florida	United States	33409
17	GSK Investigational Site	Sandy Springs	Georgia	United States	30328
18	GSK Investigational Site	Savannah	Georgia	United States	31406
19	GSK Investigational Site	Chicago	Illinois	United States	60640
20	GSK Investigational Site	Evansville	Indiana	United States	47714
21	GSK Investigational Site	Mishawaka	Indiana	United States	46544
22	GSK Investigational Site	Valparaiso	Indiana	United States	46383
23	GSK Investigational Site	Ames	Iowa	United States	50010
24	GSK Investigational Site	El Dorado	Kansas	United States	67042
25	GSK Investigational Site	Elkridge	Maryland	United States	21075
26	GSK Investigational Site	Methuen	Massachusetts	United States	01844
27	GSK Investigational Site	Minneapolis	Minnesota	United States	55402
28	GSK Investigational Site	Saint Louis	Missouri	United States	63141
29	GSK Investigational Site	Grand Island	Nebraska	United States	68803
30	GSK Investigational Site	Papillion	Nebraska	United States	68046
31	GSK Investigational Site	North Las Vegas	Nevada	United States	89030
32	GSK Investigational Site	Warren	New Jersey	United States	07059
33	GSK Investigational Site	Fayetteville	North Carolina	United States	28306
34	GSK Investigational Site	Hickory	North Carolina	United States	28601
35	GSK Investigational Site	Rocky Mount	North Carolina	United States	27804
36	GSK Investigational Site	Wilmington	North Carolina	United States	28401
37	GSK Investigational Site	Cincinnati	Ohio	United States	45236
38	GSK Investigational Site	Edmond	Oklahoma	United States	73013
39	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15243
40	GSK Investigational Site	North Charleston	South Carolina	United States	29405
41	GSK Investigational Site	Spartanburg	South Carolina	United States	29303
42	GSK Investigational Site	Jefferson City	Tennessee	United States	37760
43	GSK Investigational Site	Knoxville	Tennessee	United States	37912
44	GSK Investigational Site	Memphis	Tennessee	United States	38119
45	GSK Investigational Site	Austin	Texas	United States	78745
46	GSK Investigational Site	San Antonio	Texas	United States	78229
47	GSK Investigational Site	San Antonio	Texas	United States	78237