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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04841577




Registration number
NCT04841577
Ethics application status
Date submitted
8/04/2021
Date registered
12/04/2021
Date last updated
18/10/2022

Titles & IDs
Public title
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 60 Years and Above
Scientific title
A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above
Secondary ID [1] 0 0
214488
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSVPreF3 OA investigational vaccine
Other interventions - FLU-QIV

Experimental: Co-Ad Group - Participants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.

Active Comparator: Control Group - Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.


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

Other interventions: FLU-QIV
FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
Timepoint [1] 0 0
At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Primary outcome [2] 0 0
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
Timepoint [2] 0 0
1 month after the FLU vaccine dose (at Day 31)
Secondary outcome [1] 0 0
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)
Timepoint [1] 0 0
1 month after the FLU vaccine dose (at Day 31)
Secondary outcome [2] 0 0
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
Timepoint [2] 0 0
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Secondary outcome [3] 0 0
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)
Timepoint [3] 0 0
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Secondary outcome [4] 0 0
RSV-B Neutralization Antibody Titers Expressed as MGI
Timepoint [4] 0 0
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Secondary outcome [5] 0 0
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs
Timepoint [5] 0 0
At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
Secondary outcome [6] 0 0
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)
Timepoint [6] 0 0
At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
Secondary outcome [7] 0 0
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI
Timepoint [7] 0 0
1 month after the FLU vaccine dose (at Day 31)
Secondary outcome [8] 0 0
Percentage of Participants With Solicited Administration Site Events
Timepoint [8] 0 0
Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Secondary outcome [9] 0 0
Percentage of Participants With Solicited Systemic Events
Timepoint [9] 0 0
Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Secondary outcome [10] 0 0
Percentage of Participants Reporting at Least One Unsolicited Adverse Event
Timepoint [10] 0 0
Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination
Secondary outcome [11] 0 0
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
Timepoint [11] 0 0
From Day 1 up to study end (6 months after last vaccination)
Secondary outcome [12] 0 0
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
Timepoint [12] 0 0
From Day 1 up to study end (6 months after last vaccination)

Eligibility
Key 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 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.

- Hypersensitivity to latex.

- History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.

- 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 dose of study vaccines and ending 30 days after the last vaccine administration,
or planned use during the study period.

- Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV
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 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2022
Sample size
Target
Accrual to date
Final
976
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Havelock North
Country [4] 0 0
New Zealand
State/province [4] 0 0
Paraparaumu
Country [5] 0 0
New Zealand
State/province [5] 0 0
Tauranga
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington
Country [7] 0 0
Panama
State/province [7] 0 0
Ciudad de Panama
Country [8] 0 0
Panama
State/province [8] 0 0
Panama
Country [9] 0 0
South Africa
State/province [9] 0 0
Gauteng
Country [10] 0 0
South Africa
State/province [10] 0 0
Mpumalanga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 seasonal quadrivalent
influenza vaccine (FLU-QIV) in adults aged 60 years and above compared to separate
administration of the vaccines.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04841577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries