A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Virus Prevention

Treatments: Biological: Ad26.RSV.PreF-based Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05101486

CR109069

VAC18193RSV3003 (Other Identifier)

2021-002388-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.

Enrollment: 755 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• From the time of vaccination through 3 months after vaccination, agrees not to donate blood
• In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
• Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
• Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Must be able to work with smartphones/tablets/computers

Exclusion criteria

• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
• Abnormal function of the immune system resulting from clinical conditions or medication
• Per medical history, participant has chronic active hepatitis B or hepatitis C infection
• History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
• Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
• Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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755 participants in 3 patient groups

Group 1: Ad26.RSV.PreF-based Vaccine

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).

Treatment:

Biological: Ad26.RSV.PreF-based Vaccine

Group 2: Ad26.RSV.PreF-based Vaccine

Experimental group

Description:

Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).

Treatment:

Biological: Ad26.RSV.PreF-based Vaccine

Group 3: Ad26.RSV.PreF-based Vaccine

Experimental group

Description:

Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).

Treatment:

Biological: Ad26.RSV.PreF-based Vaccine