A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

Janssen Vaccines & Prevention B.V.13 sites in 1 country755 target enrollmentNovember 1, 2021

ConditionsRespiratory Syncytial Virus Prevention

InterventionsAd26.RSV.PreF-based Vaccine

Overview

Phase: Phase 3
Intervention: Ad26.RSV.PreF-based Vaccine
Conditions: Respiratory Syncytial Virus Prevention
Sponsor: Janssen Vaccines & Prevention B.V.
Enrollment: 755
Locations: 13
Primary Endpoint: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

September 20, 2022

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Janssen Vaccines & Prevention B.V.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1: Ad26.RSV.PreF-based Vaccine

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

Intervention: Ad26.RSV.PreF-based Vaccine

Group 2: Ad26.RSV.PreF-based Vaccine

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

Intervention: Ad26.RSV.PreF-based Vaccine

Group 3: Ad26.RSV.PreF-based Vaccine

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

Intervention: Ad26.RSV.PreF-based Vaccine

Outcomes

Primary Outcomes

Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination

Time Frame: 14 days post vaccination on Day 1 (Day 15)

GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.

Secondary Outcomes

Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination(14 days post vaccination on Day 1 (Day 15))
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination(Up to 28 days post vaccination on Day 1 (up to Day 29))
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))