Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04908683




Registration number
NCT04908683
Ethics application status
Date submitted
27/05/2021
Date registered
1/06/2021

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
Treatment: Other - Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Treatment: Other - 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.


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

Treatment: Other: Placebo
Participants will receive a single IM injection of matching placebo.
Intervention code [1] 0 0
Treatment: Other
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
South Dakota
Country [33] 0 0
United States of America
State/province [33] 0 0
Tennessee
Country [34] 0 0
United States of America
State/province [34] 0 0
Texas
Country [35] 0 0
United States of America
State/province [35] 0 0
Utah
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
Brazil
State/province [37] 0 0
Boa Vista
Country [38] 0 0
Brazil
State/province [38] 0 0
Juiz de Fora
Country [39] 0 0
Brazil
State/province [39] 0 0
Porto Alegre
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Jose do Rio Preto
Country [41] 0 0
Brazil
State/province [41] 0 0
São Paulo
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Quilota
Country [46] 0 0
Chile
State/province [46] 0 0
Santiago
Country [47] 0 0
Chile
State/province [47] 0 0
Talca
Country [48] 0 0
China
State/province [48] 0 0
Lianyungang
Country [49] 0 0
China
State/province [49] 0 0
Nanjing
Country [50] 0 0
China
State/province [50] 0 0
Yancheng
Country [51] 0 0
Estonia
State/province [51] 0 0
Tallinn
Country [52] 0 0
Estonia
State/province [52] 0 0
Tartu
Country [53] 0 0
Finland
State/province [53] 0 0
Espoo
Country [54] 0 0
Finland
State/province [54] 0 0
Helsinki
Country [55] 0 0
Finland
State/province [55] 0 0
Järvenpää
Country [56] 0 0
Finland
State/province [56] 0 0
Kokkola
Country [57] 0 0
Finland
State/province [57] 0 0
Oulu
Country [58] 0 0
Finland
State/province [58] 0 0
Pori
Country [59] 0 0
Finland
State/province [59] 0 0
Seinäjoki
Country [60] 0 0
Finland
State/province [60] 0 0
Tampere
Country [61] 0 0
Finland
State/province [61] 0 0
Turku
Country [62] 0 0
New Zealand
State/province [62] 0 0
Auckland
Country [63] 0 0
New Zealand
State/province [63] 0 0
Christchurch
Country [64] 0 0
New Zealand
State/province [64] 0 0
Hamilton
Country [65] 0 0
New Zealand
State/province [65] 0 0
Havelock North
Country [66] 0 0
New Zealand
State/province [66] 0 0
Main Road Stoke
Country [67] 0 0
New Zealand
State/province [67] 0 0
Palmerston North
Country [68] 0 0
New Zealand
State/province [68] 0 0
Paraparaumu
Country [69] 0 0
New Zealand
State/province [69] 0 0
Rotorua
Country [70] 0 0
New Zealand
State/province [70] 0 0
Tauranga
Country [71] 0 0
New Zealand
State/province [71] 0 0
Upper Hutt
Country [72] 0 0
New Zealand
State/province [72] 0 0
Wellington
Country [73] 0 0
Poland
State/province [73] 0 0
Czestochowa
Country [74] 0 0
Poland
State/province [74] 0 0
Gdansk
Country [75] 0 0
Poland
State/province [75] 0 0
Gdynia
Country [76] 0 0
Poland
State/province [76] 0 0
Katowice
Country [77] 0 0
Poland
State/province [77] 0 0
Lodz
Country [78] 0 0
Poland
State/province [78] 0 0
Lublin
Country [79] 0 0
Poland
State/province [79] 0 0
Poznan
Country [80] 0 0
Poland
State/province [80] 0 0
Pulawy
Country [81] 0 0
Poland
State/province [81] 0 0
Skorzewo
Country [82] 0 0
Poland
State/province [82] 0 0
Staszow
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Poland
State/province [84] 0 0
Wroclaw
Country [85] 0 0
Poland
State/province [85] 0 0
Zamosc
Country [86] 0 0
South Africa
State/province [86] 0 0
Bloemfontein
Country [87] 0 0
South Africa
State/province [87] 0 0
Brits
Country [88] 0 0
South Africa
State/province [88] 0 0
Cape Town
Country [89] 0 0
South Africa
State/province [89] 0 0
East London
Country [90] 0 0
South Africa
State/province [90] 0 0
George
Country [91] 0 0
South Africa
State/province [91] 0 0
Johannesburg
Country [92] 0 0
South Africa
State/province [92] 0 0
Krugersdorp
Country [93] 0 0
South Africa
State/province [93] 0 0
Mamelodi East
Country [94] 0 0
South Africa
State/province [94] 0 0
Newtown
Country [95] 0 0
South Africa
State/province [95] 0 0
Paarl
Country [96] 0 0
South Africa
State/province [96] 0 0
Pretoria
Country [97] 0 0
South Africa
State/province [97] 0 0
Rustenburg
Country [98] 0 0
South Africa
State/province [98] 0 0
Vosloorus
Country [99] 0 0
South Africa
State/province [99] 0 0
Welkom
Country [100] 0 0
South Africa
State/province [100] 0 0
Western Cape
Country [101] 0 0
Taiwan
State/province [101] 0 0
Kaohsiung
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taichung
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taipei City
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taipei
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taoyuan County
Country [106] 0 0
Thailand
State/province [106] 0 0
Bangkok
Country [107] 0 0
Thailand
State/province [107] 0 0
Khon Kaen
Country [108] 0 0
Thailand
State/province [108] 0 0
Muang
Country [109] 0 0
Thailand
State/province [109] 0 0
Pathumwan
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Birmingham
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Bradford
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Bromborough
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Cardiff
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Chorley
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Glasgow
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Hexham
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Liverpool
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Manchester
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Preston
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Reading
Country [121] 0 0
United Kingdom
State/province [121] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04908683