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 (EVERGREEN)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Viruses; Lower Respiratory Tract Disease

Treatments: Biological: Placebo; Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908683

2020-005458-97 (EudraCT Number)

CR108959

VAC18193RSV3001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25,236 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25,236 participants in 2 patient groups, including a placebo group

Group 1: Respiratory Syncytial Virus (RSV) vaccine

Experimental group

Description:

All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.

Treatment:

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

Group 2: Placebo

Placebo Comparator group

Description:

All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.

Treatment:

Biological: Placebo