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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

Primary Purpose

Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Ad26.RSV.preF-based vaccine

Quadrivalent High-dose Influenza Vaccine

Placebo

About this trial

This is an interventional prevention trial for Influenza, Human Prevention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ark Clinical Research
Research Centers of America, LLC
Progressive Medical Research
Synexus Clinical Research US, Inc
Synexus Clinical Research US, Inc
Meridian Clinical Research, LLC
Sundance Clinical Research
Synexus Clinical Research US, Inc
Meridian Clinical Research, LLC
Meridian Clinical Research, LLC
Meridian Clinical Research, LLC
Meridian Clinical Research, LLC
Tekton Research Inc.
Coastal Carolina Research Center
VitaLink Research Spartanburg
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Optimal Research
Tekton Research Inc.
DM Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1: Coadministration (CoAd) Group

Group 2: Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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]).

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.

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.

Secondary Outcome Measures

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

Number of participants with solicited local AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). Solicited local AEs were reported separately for all vaccines because fluzone and RSV vaccine mixture (containing both Ad26. RSV. preF 1*10^11 vp and RSV preF protein 150 mcg) in group 1 were administered in opposite arms on Day 1. Similarly, fluzone and placebo in group 2 were administered in opposite arms on Day 1. Hence, the data for this outcome measure was analyzed separately for each vaccine.

Number of Participants With Solicited Local AEs After Study Vaccination 2

Number of participants with solicited local AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Number of Participants With Solicited Systemic AEs After Study Vaccination 1

Number of participants with solicited systemic AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Number of Participants With Solicited Systemic AEs After Study Vaccination 2

Number of participants with solicited systemic AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Number of Participants With Unsolicited AEs After Study Vaccination 1

Number of participants with unsolicited AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

Number of Participants With Unsolicited AEs After Study Vaccination 2

Number of participants with unsolicited AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1

Number of participants with SAEs up to study vaccination 1 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2

Number of participants with SAEs up to study vaccination 2 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1

Number of participants with AESI up to study vaccination 1 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2

Number of participants with AESI up to study vaccination 2 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine

Number of seroconverted participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroconversion is defined for each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine: HI titer greater than or equal to (>=) 1:40 in participants with a pre-vaccination HI titer of less than (<) 1:10, or a >=4-fold HI titer increase in participants with a pre-vaccination HI titer of >=1:10.

Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine

Number of seroprotected participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroprotection is defined for each of the 4 influenza vaccine strains as HI titer >=1:40 at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine.

Full Information

NCT ID

NCT05071313

First Posted

September 28, 2021

Last Updated

October 11, 2023

Sponsor

Janssen Vaccines & Prevention B.V.

1. Study Identification

Unique Protocol Identification Number

NCT05071313

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 4, 2021 (Actual)

Primary Completion Date

April 20, 2022 (Actual)

Study Completion Date

October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

777 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Coadministration (CoAd) Group

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2: Control Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Ad26.RSV.preF-based vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Quadrivalent High-dose Influenza Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Number of Participants With Solicited Local AEs After Study Vaccination 2

Description

Time Frame

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

Title

Number of Participants With Solicited Systemic AEs After Study Vaccination 1

Description

Time Frame

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

Title

Number of Participants With Solicited Systemic AEs After Study Vaccination 2

Description

Time Frame

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

Title

Number of Participants With Unsolicited AEs After Study Vaccination 1

Description

Time Frame

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

Title

Number of Participants With Unsolicited AEs After Study Vaccination 2

Description

Time Frame

Up to 28 days after study vaccination 2 on Day 29 (Day 57)

Title

Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1

Description

Time Frame

From Day 1 up to Day 29

Title

Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2

Description

Time Frame

From Day 29 up to 6 months after study vaccination 2 (up to 7 months)

Title

Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1

Description

Number of participants with AESI up to study vaccination 1 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Time Frame

From Day 1 up to Day 29

Title

Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2

Description

Number of participants with AESI up to study vaccination 2 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Time Frame

From Day 29 up to 6 months after study vaccination 2 (up to 7 months)

Title

Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine

Description

Time Frame

28 days after vaccination with fluzone on Day 1 (up to Day 29)

Title

Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine

Description

Time Frame

28 days after vaccination with fluzone on Day 1 (up to Day 29)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Vaccines & Prevention B.V. Clinical Trial

Organizational Affiliation

Janssen Vaccines & Prevention B.V.

Official's Role

Study Director

Facility Information:

Facility Name

Ark Clinical Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Research Centers of America, LLC

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Progressive Medical Research

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Synexus Clinical Research US, Inc

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162

Country

United States

Facility Name

Synexus Clinical Research US, Inc

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20854

Country

United States

Facility Name

Sundance Clinical Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Synexus Clinical Research US, Inc

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68803

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Norfolk

State/Province

Nebraska

ZIP/Postal Code

68701

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Tekton Research Inc.

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

Coastal Carolina Research Center

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29405

Country

United States

Facility Name

VitaLink Research Spartanburg

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

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

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Optimal Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Tekton Research Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

DM Clinical Research

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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