HealthyPhase 2NCT03339713

A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

A Phase 2 study testing Ad26.RSV.preF and Fluarix in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site 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

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ad26.RSV.preF and Fluarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteUnited States
Study dates: 7 Dec 2017to 23 Jul 2018
Phase: Phase 2
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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
Before randomization, a woman must be:
Postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and
Not intending to conceive by any methods
In the investigator's clinical judgment, participant must be either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1
From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Who cannot join

Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine
Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

Trial locations and contacts

1 site in 1 country.

United States1 site

Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and Ad26.RSV.preF, With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1*10^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.

Conditions: Healthy
Being tested: Ad26.RSV.preF, Fluarix, Placebo

What participants receive

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

Ad26.RSV.preFBiological
Also called JNJ-64400141
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.
FluarixBiological
Fluarix will be administered as intramuscular injection.
PlaceboBiological
Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.

Study groups in NCT03339713
Study group	Role	What they receive
Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1	Experimental	Participants will receive intramuscular injection of 1*10^11 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on 1 arm administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on the other arm at Day 1, and intramuscular injection of placebo on Day 29. Receives: Biological: Ad26.RSV.preF; Biological: Fluarix; Biological: Placebo
Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2	Experimental	Participants will receive intramuscular injection of placebo administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on Day 1, and 1*10^11 vp of Ad26.RSV.preF on Day 29. Receives: Biological: Ad26.RSV.preF; Biological: Fluarix; Biological: Placebo

What is being measured

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

Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants.
Measured: 28 days after vaccination (Day 29)
Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)
Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Measured: Up to 7 days post-dose 1 on Day 1 (Day 8)
Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs
Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Measured: Up to 7 days post-dose 2 on Day 29 (Day 36)
Post-dose 1: Percentage of Participants With Unsolicited AEs
Percentage of participants with unsolicited AEs were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Measured: Up to 28 days post-dose 1 on Day 1 (Day 29)
Post-dose 2: Percentage of Participants With Unsolicited AEs
Percentage of participants with unsolicited AEs 2 were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Measured: Up to 28 days post-dose 2 on Day 29 (Day 57)
Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 6 months post-dose 1 (Day 183)
Post-dose 2: Percentage of Participants With SAEs
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 6 months post-dose 2 (Day 211)

Secondary outcomes (3)

Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Measured: Baseline and Day 29 (post Ad26.RSV.preF)
RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
GMT (ELISA units per litre [EU/L]) of RSV F protein in pre-fusion form by ELISA was reported.
Measured: Baseline and Day 29 (post Ad26.RSV.preF)
RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion
GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported.
Measured: Baseline and Day 29 (post Ad26.RSV.preF)

Timeline

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

7 Dec 201723 Jul 2018

First posted13 Nov 2017
Study start7 Dec 2017
Primary completion23 Jul 2018
Study completion23 Jul 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339713
Sponsor's protocol ID: CR108403
Other IDs: VAC18193RSV2003
Status last verified: Jan 2025
First submitted: 8 Nov 2017
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Sadoff J, De Paepe E, Haazen W, Omoruyi E, Bastian AR, Comeaux C, Heijnen E, Strout C, Schuitemaker H, Callendret B. Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults. J Infect Dis. 2021 Feb 24;223(4):699-708. doi: 10.1093/infdis/jiaa409.
PubMed 32851411

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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and Ad26.RSV.preF, With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
ClinicalTrials.gov ID: NCT03339713
Acronym / sponsor ID: CR108403
Conditions: Healthy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 7 Dec 2017 (actual)
Primary completion: 23 Jul 2018 (actual)
Study completion: 23 Jul 2018 (actual)
First posted: 13 Nov 2017 (actual)
Results: Posted 18 Aug 2021

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
Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1	Experimental	Biological: Ad26.RSV.preF, Biological: Fluarix, Biological: PlaceboParticipants will receive intramuscular injection of 1*10^11 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on 1 arm administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on the other arm at Day 1, and intramuscular injection of placebo on Day 29.
Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2	Experimental	Biological: Ad26.RSV.preF, Biological: Fluarix, Biological: PlaceboParticipants will receive intramuscular injection of placebo administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on Day 1, and 1*10^11 vp of Ad26.RSV.preF on Day 29.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
Before randomization, a woman must be:
In the investigator's clinical judgment, participant must be either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1
From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Key exclusion criteria (5 listed)

Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine
Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

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.preFAlso: JNJ-64400141Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.	Biological	Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1, Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2
FluarixFluarix will be administered as intramuscular injection.	Biological	Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1, Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2
PlaceboPlacebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.	Biological	Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1, Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2

Primary outcome

Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
Time frame: 28 days after vaccination (Day 29)
Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants.
Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)
Time frame: Up to 7 days post-dose 1 on Day 1 (Day 8)
Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs
Time frame: Up to 7 days post-dose 2 on Day 29 (Day 36)
Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Post-dose 1: Percentage of Participants With Unsolicited AEs
Time frame: Up to 28 days post-dose 1 on Day 1 (Day 29)
Percentage of participants with unsolicited AEs were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Post-dose 2: Percentage of Participants With Unsolicited AEs
Time frame: Up to 28 days post-dose 2 on Day 29 (Day 57)
Percentage of participants with unsolicited AEs 2 were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 6 months post-dose 1 (Day 183)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Post-dose 2: Percentage of Participants With SAEs
Time frame: Up to 6 months post-dose 2 (Day 211)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

3 secondary outcomes

Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
Time frame: Baseline and Day 29 (post Ad26.RSV.preF)
RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
Time frame: Baseline and Day 29 (post Ad26.RSV.preF)
RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion
Time frame: Baseline and Day 29 (post Ad26.RSV.preF)

Results and safety

Results posted to the registry on 18 Aug 2021, 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.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	90	86
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	90	88

Primary outcome: Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains

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

Measure	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo n = 85	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) n = 89
A/Michigan strain	215 (160 to 289)	168 (125 to 226)
A/Hong Kong strain	98 (73 to 131)	80 (61 to 103)
B/Brisbane strain	39 (31 to 49)	40 (31 to 51)
B/Phuket strain	35 (28 to 43)	35 (27 to 46)

Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo vs Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp): Geometric Mean Ratio: 0.8 (90% CI 0.55 to 1.11), p <.001, t-test, 1 sided
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo vs Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp): Geometric Mean Ratio: 0.8 (90% CI 0.59 to 1.12), p <.001, t-test, 1 sided
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo vs Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp): Geometric Mean Ratio: 1.0 (90% CI 0.77 to 1.34), p <.001, t-test, 1 sided

Population analysed: The Per-protocol influenza immunogenicity (PPII) set included participants who were randomized and received the first vaccination for whom immunogenicity data are available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Primary outcome: Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)

Time frame: Up to 7 days post-dose 1 on Day 1 (Day 8). Number. Unit: Percentage of participants

Measure	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo n = 90	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) n = 90
Post-dose 1: Solicited local AEs	80.0	45.6
Post-dose 1: Solicited systemic AEs	63.3	27.8

Primary outcome: Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs

Time frame: Up to 7 days post-dose 2 on Day 29 (Day 36). Number. Unit: Percentage of participants

Measure	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo n = 88	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) n = 90
Post-dose 2: Solicited local AEs	6.8	76.7
Post-dose 2: Solicited systemic AEs	18.2	70.0

Population analysed: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations and vaccine type (seasonal influenza, Ad26.RSV.preF or placebo). Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Primary outcome: Post-dose 1: Percentage of Participants With Unsolicited AEs

Time frame: Up to 28 days post-dose 1 on Day 1 (Day 29). Number. Unit: Percentage of participants

Measure	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo n = 90	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) n = 90
Value	36.7	33.3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)	0 of 90 (0%)	22 of 90 (24.4%)	0 of 90
Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)	0 of 90 (0%)	18 of 90 (20%)	0 of 90
Group 1 Post-Dose 2: Placebo (Day 29)	1 of 88 (1.1%)	13 of 88 (14.8%)	0 of 88
Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)	1 of 90 (1.1%)	14 of 90 (15.6%)	0 of 90

Limitations and caveats (from the sponsor): Although qualification of the site was satisfactory for peripheral blood mononuclear cells (PBMC) processing,during the study PBMC processing resulted in much lower yield than expected, which have affected the quality of PBMC. While sample quality requirements on sample viability were met for most samples,viability was considered lower than commonly expected.An indication of possible suboptimal quality of PBMC samples were also be a low baseline responses observed in comparison to other studies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32851411Sadoff J, De Paepe E, Haazen W, Omoruyi E, Bastian AR, Comeaux C, Heijnen E, Strout C, Schuitemaker H, Callendret B. Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults. J Infect Dis. 2021 Feb 24;223(4):699-708. doi: 10.1093/infdis/jiaa409.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.RSV.preF and Fluarix in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.

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 7 inclusion and 5 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 Aug 2021). 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?

Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains (time frame: 28 days after vaccination (Day 29)). The study lists 7 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 NCT03339713, which also lists 1 linked publication.

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 4 Feb 2025.