Influenza, Human PreventionPhase 3NCT05071313

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

A Phase 3 study testing Ad26.RSV.preF-based vaccine and Quadrivalent High-dose Influenza Vaccine in people with Influenza, Human Prevention and Respiratory Syncytial Viruses Prevention, run by Janssen Vaccines & Prevention B.V. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention
What is being tested?: Ad26.RSV.preF-based vaccine and Quadrivalent High-dose Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 777 participants
Where: 19 sitesUnited States
Study dates: 4 Oct 2021to 11 Oct 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Optimal Research
Austin, Texas, 78705
Tekton Research Inc.
Austin, Texas, 78745
Synexus Clinical Research US Inc
Chicago, Illinois, 60602
Meridian Clinical Research, LLC
Grand Island, Nebraska, 68803
Research Centers of America, LLC
Hollywood, Florida, 33024
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, 37920
Meridian Clinical Research, LLC
Lincoln, Nebraska, 68510
Ark Clinical Research
Long Beach, California, 90806
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Progressive Medical Research
Port Orange, Florida, 32127
Meridian Clinical Research, LLC
Rockville, Maryland, 20854
VitaLink Research Spartanburg
Spartanburg, South Carolina, 29303
Sundance Clinical Research
St Louis, Missouri, 63141
Synexus Clinical Research US Inc
St Louis, Missouri, 63141
Synexus Clinical Research US Inc
The Villages, Florida, 32162
DM Clinical Research
Tomball, Texas, 77375
Tekton Research Inc.
Yukon, Oklahoma, 73099

Other trials in United States

About this study

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

Conditions: Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention
Being tested: Ad26.RSV.preF-based vaccine, Quadrivalent High-dose Influenza Vaccine, Placebo
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ad26.RSV.preF-based vaccineBiological
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Quadrivalent High-dose Influenza VaccineBiological
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
PlaceboBiological
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.

Study groups in NCT05071313
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Ad26.RSV.preF-based vaccine; Biological: Quadrivalent High-dose Influenza Vaccine; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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]).
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
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).
Measured: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
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).
Measured: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
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).
Measured: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
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.
Measured: Up to 28 days after study vaccination 1 on Day 1 (Day 29)
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.
Measured: Up to 28 days after study vaccination 2 on Day 29 (Day 57)
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.
Measured: From Day 1 up to Day 29
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.
Measured: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
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.
Measured: From Day 1 up to Day 29
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.
Measured: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
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.
Measured: 28 days after vaccination with fluzone on Day 1 (up to Day 29)
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.
Measured: 28 days after vaccination with fluzone on Day 1 (up to Day 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202111 Oct 2022

First posted8 Oct 2021
Study start4 Oct 2021
Primary completion20 Apr 2022
Study completion11 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Influenza, Human PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 777 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05071313
Sponsor's protocol ID: CR109064
Other IDs: VAC18193RSV3005
Status last verified: May 2025
First submitted: 28 Sep 2021
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05071313
Acronym / sponsor ID: CR109064
Conditions: Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 777 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 4 Oct 2021 (actual)
Primary completion: 20 Apr 2022 (actual)
Study completion: 11 Oct 2022 (actual)
First posted: 8 Oct 2021 (actual)
Results: Posted 13 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1: Coadministration (CoAd) Group	Experimental	Biological: Ad26.RSV.preF-based vaccine, Biological: Quadrivalent High-dose Influenza Vaccine, Biological: PlaceboParticipants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
Group 2: Control Group	Experimental	Biological: Ad26.RSV.preF-based vaccine, Biological: Quadrivalent High-dose Influenza Vaccine, Biological: PlaceboParticipants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ad26.RSV.preF-based vaccineAd26.RSV.preF-based vaccine will be administered as single IM injection.	Biological	Group 1: Coadministration (CoAd) Group, Group 2: Control Group
Quadrivalent High-dose Influenza VaccineQuadrivalent High-dose Influenza Vaccine will be administered as IM injection.	Biological	Group 1: Coadministration (CoAd) Group, Group 2: Control Group
PlaceboPlacebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.	Biological	Group 1: Coadministration (CoAd) Group, Group 2: Control Group

Primary outcome

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
Time frame: 28 days after vaccination with Fluzone on Day 1 (Day 29)
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
Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (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
Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (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.

12 secondary outcomes

Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1
Time frame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
Number of Participants With Solicited Local AEs After Study Vaccination 2
Time frame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
Number of Participants With Solicited Systemic AEs After Study Vaccination 1
Time frame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)
Number of Participants With Solicited Systemic AEs After Study Vaccination 2
Time frame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)
Number of Participants With Unsolicited AEs After Study Vaccination 1
Time frame: Up to 28 days after study vaccination 1 on Day 1 (Day 29)
Number of Participants With Unsolicited AEs After Study Vaccination 2
Time frame: Up to 28 days after study vaccination 2 on Day 29 (Day 57)
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1
Time frame: From Day 1 up to Day 29
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2
Time frame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1
Time frame: From Day 1 up to Day 29
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2
Time frame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine
Time frame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)
Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine
Time frame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)

Results and safety

Results posted to the registry on 13 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)	389	355
Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)	388	355

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

Time frame: 28 days after vaccination with Fluzone on Day 1 (Day 29). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) n = 338	Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) n = 338
A/Victoria	178 (145 to 217)	179 (146 to 219)
A/Tasmania	111 (89 to 139)	123 (98 to 155)
B/Washington	93 (74 to 117)	84 (67 to 106)
B/Phuket	38 (31 to 47)	37 (30 to 46)

Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group): Geometric Mean Ratio: 1.01 (95% CI 0.89 to 1.14)
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group): Geometric Mean Ratio: 1.11 (95% CI 0.97 to 1.28)
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group): Geometric Mean Ratio: 0.91 (95% CI 0.79 to 1.05)

Population analysed: Per-protocol influenza immunogenicity (PPII) set included all randomized participants who received the first study vaccination, and for whom immunogenicity data are available for at least one of the influenza strains in the vaccine. Samples taken after participant experienced major protocol deviation expected to impact the immunogenicity outcomes were excluded from this analysis, including those who were collected out of window.

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

Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29). Geometric mean (95% Confidence Interval). Unit: ELISA units per liter (EU/L)

Measure	Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) n = 338
Value	2665 (2209 to 3216)

Population analysed: Per-protocol RSV immunogenicity (PPRI) set included all randomized participants who received Ad26/protein preF RSV vaccine in combination with seasonal influenza vaccine in the CoAd group and Ad26/protein preF RSV vaccine alone in the control group and for which RSV immunogenicity data were available. Samples taken after participant experienced major protocol deviation expected to impact immunogenicity outcomes were excluded from this analysis, including those who were collected out of window.

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

Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57). Geometric mean (95% Confidence Interval). Unit: EU/L

Measure	Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) n = 318
Value	3206 (2648 to 3881)

Population analysed: The PPRI set included all randomized participants who received Ad26/protein preF RSV vaccine in combination with seasonal influenza vaccine for the CoAd group and Ad26/protein preF RSV vaccine alone for the control group and for whom RSV immunogenicity data were available. Samples taken after participant experienced major protocol deviation expected to impact the immunogenicity outcomes were excluded from this analysis, including those who were collected out of window.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 up to 7 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)	2 of 385 (0.5%)	18 of 385 (4.7%)	0 of 385
Group 2: Fluzone HD QIV With Placebo (Control Group)	2 of 386 (0.5%)	12 of 386 (3.1%)	0 of 386
Group 1: Placebo (CoAd Group)	11 of 357 (3.1%)	1 of 357 (0.3%)	1 of 357
Group 2: Ad26/Protein preF RSV Vaccine (Control Group)	11 of 363 (3%)	10 of 363 (2.8%)	0 of 363

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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

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Healthy Participants
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
RecruitingPhase 3
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
Influenza, Human, Respiratory Tract Infections
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay (time frame: 28 days after vaccination with Fluzone on Day 1 (Day 29)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05071313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.