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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/NCT04908683




Registration number
NCT04908683
Ethics application status
Date submitted
27/05/2021
Date registered
1/06/2021
Date last updated
8/02/2024

Titles & IDs
Public title
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
Secondary ID [1] 0 0
2020-005458-97
Secondary ID [2] 0 0
CR108959
Universal Trial Number (UTN)
Trial acronym
EVERGREEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses 0 0
Lower Respiratory Tract Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Other interventions - Placebo

Experimental: Group 1: Respiratory Syncytial Virus (RSV) vaccine - All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.

Placebo Comparator: Group 2: Placebo - All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.


Other interventions: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Participants will receive a single IM injection of an RSV vaccine.

Other interventions: Placebo
Participants will receive a single IM injection of matching placebo.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
Timepoint [1] 0 0
From Baseline (Day 1) up to 12 months
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Timepoint [1] 0 0
From Baseline (Day 1) up to 12 months
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
Timepoint [2] 0 0
From Month 12 up to Month 24
Secondary outcome [3] 0 0
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
Timepoint [3] 0 0
From Month 12 up to Month 24
Secondary outcome [4] 0 0
Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
Timepoint [4] 0 0
Baseline (Day 1) up to 24 months
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Secondary outcome [6] 0 0
Number of Participants With Potential Adverse Events of Special Interest (AESIs)
Timepoint [6] 0 0
28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Secondary outcome [7] 0 0
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
Timepoint [7] 0 0
Up to Day 7 post vaccination on Day 1 (up to Day 8)
Secondary outcome [8] 0 0
Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
Timepoint [8] 0 0
Up to Day 7 post vaccination on Day 1 (up to Day 8)
Secondary outcome [9] 0 0
Number of Participants With Unsolicited AEs up to 28 Days After Vaccination
Timepoint [9] 0 0
Up to 28 days post vaccination on Day 1 (up to Day 29)
Secondary outcome [10] 0 0
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
Timepoint [10] 0 0
At 14 Days post vaccination on Day 1 (Day 15)
Secondary outcome [11] 0 0
Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination
Timepoint [11] 0 0
At 14 days post vaccination on Day 1 (Day 15)
Secondary outcome [12] 0 0
T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Timepoint [12] 0 0
14 days post vaccination on Day 1 (Day 15)
Secondary outcome [13] 0 0
Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Timepoint [13] 0 0
Baseline (Day 1) up to 24 months

Eligibility
Key inclusion criteria
- Must be able to work with smartphones/tablets/computers

- From the time of vaccination through 3 months after vaccination, participant agrees
not to donate blood

- Must be willing to provide verifiable identification, has means to be contacted and to
contact the investigator during the study

- Before randomization, a participant must be: a. postmenopausal (postmenopausal state
is defined as no menses for 12 months without an alternative medical cause); and b.
not intending to conceive by any methods

- Participants must sign an Inform Consent Form (ICF) indicating that the participant
understands the purpose, procedures and potential risks and benefits of the study, and
is willing to participate in the study
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Has a serious clinically unstable condition, (example, end-stage renal disease with or
without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any
other condition for which, in the opinion of the investigator, participation would not
be in the best interest of the participant (example, compromise well-being) or that
could prevent, confound, or limit the protocol specified assessments

- History of malignancy within 5 years before screening not in the following categories:
a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in
situ of the cervix may be enrolled at the discretion of the investigator; b.
Participants with a history of malignancy within 5 years, which is considered cured
with minimal risk of recurrence per investigator's judgement, can be enrolled

- Had major surgery (example, major cardiopulmonary or abdominal operations) as per the
investigator's judgment within 4 weeks before vaccination, or will not have fully
recovered from surgery, or has major surgery planned during the time the participant
is expected to participate in the study

- Employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well
as family members of the employees or the investigator, or an employee of the sponsor

- Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding
disorders)

- Known or suspected allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or vaccine components (including any of the constituents of the
study vaccine)

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
21/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/07/2023
Sample size
Target
Accrual to date
Final
25236
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical Canberra Clinic - Bruce
Recruitment hospital [2] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2059 - Kanwal
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Paarl
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Pretoria
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South Africa
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Rustenburg
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Vosloorus
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South Africa
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Welkom
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Western Cape
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Taiwan
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Kaohsiung
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Thailand
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Muang
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Thailand
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Pathumwan
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United Kingdom
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Birmingham
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Bradford
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Bromborough
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Cardiff
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Chorley
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Glasgow
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Hexham
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Liverpool
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Manchester
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Preston
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Reading
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United Kingdom
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Stockton on Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Vaccines & Prevention B.V.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the
active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription
Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower
Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04908683
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Vaccines & Prevention B.V. Clinical Trial
Address 0 0
Janssen Vaccines & Prevention B.V.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04908683