A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT05059301

Collaborator

(none)

757

Enrollment

Locations

Arms

8.9

Actual Duration (Months)

37.9

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).

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

Study Design

Study Type:

Interventional

Actual Enrollment :

757 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Study is double blind from start to final analysis after which the study is considered single blind.

Primary Purpose:

Prevention

Official Title:

A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Jan 24, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RSVPreF3_Grp1 Group Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and are followed up until the study end (Month 6).	Biological: RSVPreF3 OA investigational vaccine One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.
Experimental: RSVPreF3_Grp2 Group Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and are followed up until the study end (Month 6).	Biological: RSVPreF3 OA investigational vaccine One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.
Experimental: RSVPreF3_Grp3 Group Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and are followed up until the study end (Month 6).	Biological: RSVPreF3 OA investigational vaccine One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.

Arm

Intervention/Treatment

Experimental: RSVPreF3_Grp1 Group

Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and are followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.

Experimental: RSVPreF3_Grp2 Group

Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and are followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

Experimental: RSVPreF3_Grp3 Group

Participants receive 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and are followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

Outcome Measures

Primary Outcome Measures

RSVPreF3 specific immunoglobin (Ig)G antibody concentrations expressed as group geometric mean concentration (GMC) ratio at 30 days post-vaccination [At 30 days post-vaccination (Day 31)]
Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by Enzyme-Linked Immunosorbent Assay (ELISA). RSVPreF3 IgG concentrations are expressed as group GMC ratio.

Secondary Outcome Measures

RSVPreF3 specific IgG antibody concentrations expressed as mean geometric increase (MGI) at 30 days post-vaccination [At 30 days post-vaccination (Day 31)]
Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. RSVPreF3 IgG concentrations are expressed as MGI.
Percentage of participants reporting solicited administration site events [Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration]
Assessed solicited administration site events include pain, redness and swelling.
Percentage of participants reporting solicited systemic events [Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration]
Assessed solicited systemic events include fever, headache, myalgia, arthralgia and fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F regardless of the location of measurement.
Percentage of participants reporting unsolicited adverse events (AEs) [Within 30 days (the day of vaccination and 29 subsequent days) after study intervention administration]
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Percentage of participants reporting serious adverse events (SAEs) [From Day 1 up to study end (6 months after vaccination)]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant.
Percentage of participants reporting potential immune-mediated diseases (pIMDs) [From Day 1 up to study end (6 months after vaccination)]
pIMDs are a subset of adverse events of specific interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 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 ≥ 60 YOA at the time of 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 vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, can 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 study intervention(s).
Hypersensitivity to latex.
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.
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 intervention(s) during the period beginning 30 days before study intervention administration and ending 30 days after study intervention administration, or planned use during the study period.
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 the study intervention 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.
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 administration of the study intervention 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 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.

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 vaccine/product (drug or 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 period that will prohibit participating in the study until study end.
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	Waterbury	Connecticut	United States	06708
2	GSK Investigational Site	Brooksville	Florida	United States	34613
3	GSK Investigational Site	Immokalee	Florida	United States	34142
4	GSK Investigational Site	Buford	Georgia	United States	30519
5	GSK Investigational Site	Minneapolis	Minnesota	United States	55402
6	GSK Investigational Site	Petal	Mississippi	United States	39465
7	GSK Investigational Site	Omaha	Nebraska	United States	68144
8	GSK Investigational Site	Charlotte	North Carolina	United States	28210
9	GSK Investigational Site	Greensboro	North Carolina	United States	27408
10	GSK Investigational Site	Houston	Texas	United States	77058
11	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 1K3
12	GSK Investigational Site	Moncton	New Brunswick	Canada	E1G1A7
13	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
14	GSK Investigational Site	Toronto	Ontario	Canada	M3J 2C5
15	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1J 2G2
16	GSK Investigational Site	St-Charles-Borromée	Quebec	Canada	J6E 2B4
17	GSK Investigational Site	Quebec		Canada	G1W 4R4
18	GSK Investigational Site	Eskilstuna		Sweden	SE-631 88
19	GSK Investigational Site	Karlskrona		Sweden	SE-371 79
20	GSK Investigational Site	Uppsala		Sweden	SE-752 37

Sponsors and Collaborators

GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT05059301

Other Study ID Numbers:

217131
2021-002225-18

First Posted:

Sep 28, 2021

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by GlaxoSmithKline

Respiratory syncytial virus

Adults aged 60 years and above

Lot-to-lot consistency

Safety

Reactogenicity

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Aug 8, 2022