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

NCT05071313 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CR109064VAC18193RSV3005
• Study Type: interventional
• Target: 777
• Locations: 1 country
• Sites: 19

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.

Conditions

Influenza, Human Prevention; Respiratory Syncytial Viruses Prevention

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay

  Hemagglutination is a phenomenon by which the hemagglutinin protein of influenza viruses can bind to sialic acid receptors on the red blood cell membrane, thereby forming clumps and is the basis for the HI assay. GMTs of HI antibodies against each of the four influenza vaccine strains as measured by HI assay at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine (fluzone) were reported. The analysis was performed on 2 influenza A strains \[A/Victoria and A/Tasmania\] and 2 influenza B strains \[B/Washington and B/Phuket\]).

  28 days after vaccination with Fluzone on Day 1 (Day 29)

• GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29

  GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 29 were reported. This outcome measure was planned to be analyzed for specified arm only.

  28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29)

• GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57

  GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 57 were reported. This outcome measure was planned to be analyzed for specified arm only.

  28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57)

Secondary Outcomes (12)

• Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1

  Up to 7 days after study vaccination 1 on Day 1 (Day 8)

• Number of Participants With Solicited Local AEs After Study Vaccination 2

  Up to 7 days after study vaccination 2 on Day 29 (Day 36)

• Number of Participants With Solicited Systemic AEs After Study Vaccination 1

  Up to 7 days after study vaccination 1 on Day 1 (Day 8)

• Number of Participants With Solicited Systemic AEs After Study Vaccination 2

  Up to 7 days after study vaccination 2 on Day 29 (Day 36)

• Number of Participants With Unsolicited AEs After Study Vaccination 1

  Up to 28 days after study vaccination 1 on Day 1 (Day 29)

Study Arms (2)

Group 1: Coadministration (CoAd) Group

EXPERIMENTAL

Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.

Biological: Ad26.RSV.preF-based vaccine; Biological: Quadrivalent High-dose Influenza Vaccine; Biological: Placebo

Group 2: Control Group

EXPERIMENTAL

Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.

Biological: Ad26.RSV.preF-based vaccine; Biological: Quadrivalent High-dose Influenza Vaccine; Biological: Placebo

Interventions

Ad26.RSV.preF-based vaccine BIOLOGICAL

Ad26.RSV.preF-based vaccine will be administered as single IM injection.

Group 1: Coadministration (CoAd) Group; Group 2: Control Group

Quadrivalent High-dose Influenza Vaccine BIOLOGICAL

Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.

Group 1: Coadministration (CoAd) Group; Group 2: Control Group

Placebo BIOLOGICAL

Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.

Group 1: Coadministration (CoAd) Group; Group 2: Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (19)

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Synexus Clinical Research US Inc

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US Inc

Chicago, Illinois, 60602, United States

Location

Meridian Clinical Research, LLC

Rockville, Maryland, 20854, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Synexus Clinical Research US Inc

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research, LLC

Lincoln, Nebraska, 68510, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

VitaLink Research Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, 37920, United States

Location

Optimal Research

Austin, Texas, 78705, United States

Location

Tekton Research Inc.

Austin, Texas, 78745, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Director Biomarkers Viral Vaccines
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: October 4, 2021
• Primary Completion: April 20, 2022
• Study Completion: October 11, 2022
• Last Updated: May 25, 2025
• Results First Posted: September 13, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (19)