A Phase 2 interventional study of Ad26.RSV.preF and Fluarix in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 2, Interventional, and Prevention
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.
Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Before randomization, a woman must be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Ad26.RSV.preF · Biological: Fluarix · Biological: Placebo
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.
Biological: Ad26.RSV.preF · Biological: Fluarix · Biological: Placebo
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp.
Also known as: JNJ-64400141
Fluarix will be administered as intramuscular injection.
Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months post-dose 2 (Day 211)
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.
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
GMT (ELISA units per litre \[EU/L\]) of RSV F protein in pre-fusion form by ELISA was reported.
Time frame: 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.
Time frame: Baseline and Day 29 (post Ad26.RSV.preF)
| Milestone | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Started | 90 | 90 |
| Completed | 86 | 88 |
| Not completed | 4 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Titers | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| 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) |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 1: Solicited local AEs | 80.0 | 45.6 |
| Post-dose 1: Solicited systemic AEs | 63.3 | 27.8 |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 2: Solicited local AEs | 6.8 | 76.7 |
| Post-dose 2: Solicited systemic AEs | 18.2 | 70.0 |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 1: Percentage of Participants With Unsolicited AEs | 36.7 | 33.3 |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 2: Percentage of Participants With Unsolicited AEs | 18.2 | 18.9 |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) | 0 | 0 |
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.
| Percentage of participants | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Post-dose 2: Percentage of Participants With SAEs | 1 | 1 |
RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay.
| Titers | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Baseline | 497 (429 to 576) | 539 (458 to 636) |
| Day 29 | 1404 (1208 to 1633) | 1690 (1433 to 1993) |
GMT (ELISA units per litre \[EU/L\]) of RSV F protein in pre-fusion form by ELISA was reported.
| EU/L | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Baseline | 333 (289 to 384) | 315 (267 to 371) |
| Day 29 | 781 (694 to 879) | 814 (711 to 932) |
GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported.
| EU/L | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|
| Baseline | 256 (223 to 295) | 236 (203 to 274) |
| Day 29 | 506 (444 to 577) | 484 (426 to 549) |
Collected over 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).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1) | 0/90 (0%) | 0/90 (0%) | 22/90 (24.4%) |
| Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1) | 0/90 (0%) | 0/90 (0%) | 18/90 (20%) |
| Group 1 Post-Dose 2: Placebo (Day 29) | 0/88 (0%) | 1/88 (1.1%) | 13/88 (14.8%) |
| Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29) | 0/90 (0%) | 1/90 (1.1%) | 14/90 (15.6%) |
| Event | Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1) | Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1) | Group 1 Post-Dose 2: Placebo (Day 29) | Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29) |
|---|---|---|---|---|
| BradycardiaCardiac disorders | 0/90 | 0/90 | 1/88 | 0/90 |
| Renal InjuryRenal and urinary disorders | 0/90 | 0/90 | 1/88 | 0/90 |
| Hypertensive EmergencyVascular disorders | 0/90 | 0/90 | 1/88 | 0/90 |
| SyncopeNervous system disorders | 0/90 | 0/90 | 0/88 | 1/90 |
| Event | Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1) | Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1) | Group 1 Post-Dose 2: Placebo (Day 29) | Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29) |
|---|---|---|---|---|
| Respiratory Tract InfectionInfections and infestations | 10/90 | 11/90 | 7/88 | 5/90 |
| Blood Pressure IncreasedInvestigations | 5/90 | 4/90 | 3/88 | 5/90 |
| DiarrhoeaGastrointestinal disorders | 1/90 | 0/90 | 2/88 | 0/90 |
| GastroenteritisInfections and infestations | 0/90 | 0/90 | 2/88 | 0/90 |
| LacerationInjury, poisoning and procedural complications | 0/90 | 0/90 | 2/88 | 0/90 |
| HeadacheNervous system disorders | 2/90 | 1/90 | 2/88 | 0/90 |
| Injection Site PruritusGeneral disorders | 1/90 | 0/90 | 0/88 | 2/90 |
| Urinary Tract InfectionInfections and infestations | 2/90 | 2/90 | 0/88 | 0/90 |
| HypertensionVascular disorders | 1/90 | 0/90 | 0/88 | 2/90 |
| Age, Continuous(years) | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Total |
|---|---|---|---|
| Median | 64 (60 to 82) | 66 (60 to 81) | 65 (60 to 82) |
| Sex: Female, Male(Participants) | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Total |
|---|---|---|---|
| Female | 57 | 56 | 113 |
| Male | 33 | 34 | 67 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 89 | 89 | 178 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 19 |
| White | 79 | 81 | 160 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Total |
|---|---|---|---|
| UNITED STATES | 90 | 90 | 180 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AD26.RSV.PREF
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