Clinical trial NCT05071313: A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human Prevention
Respiratory Syncytial Viruses Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-10-08
Enrollment: 777
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.


Eligibility criteria: Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
* Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
* Participant must be able to work with smartphones/tablets/computers

Exclusion Criteria:

* 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 before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
* 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)
* History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
* Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
timeFrame: 28 days after vaccination with Fluzone on Day 1 (Day 29)
measure: GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29
timeFrame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29)
measure: GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57
timeFrame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57)
Secondary outcomes:
measure: Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1
timeFrame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
measure: Number of Participants With Solicited Local AEs After Study Vaccination 2
timeFrame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
measure: Number of Participants With Solicited Systemic AEs After Study Vaccination 1
timeFrame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
measure: Number of Participants With Solicited Systemic AEs After Study Vaccination 2
timeFrame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
measure: Number of Participants With Unsolicited AEs After Study Vaccination 1
timeFrame: Up to 28 days after study vaccination 1 on Day 1 (Day 29)
measure: Number of Participants With Unsolicited AEs After Study Vaccination 2
timeFrame: Up to 28 days after study vaccination 2 on Day 29 (Day 57)
measure: Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1
timeFrame: From Day 1 up to Day 29
measure: Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2
timeFrame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
measure: Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1
timeFrame: From Day 1 up to Day 29
measure: Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2
timeFrame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
measure: Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine
timeFrame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)
measure: Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine
timeFrame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Chicago
country: United States
facility: Synexus Clinical Research US Inc
state: Illinois
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US Inc
state: Missouri
city: Grand Island
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research Spartanburg
state: South Carolina
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Austin
country: United States
facility: Tekton Research Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: