Respiratory Syncytial Virus PreventionPhase 3NCT05101486
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
A Phase 3 study testing Ad26.RSV.PreF-based Vaccine in people with Respiratory Syncytial Virus Prevention, run by Janssen Vaccines & Prevention B.V. at 13 sites in United States.
Trial summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Prevention
- What is being tested?
- Ad26.RSV.PreF-based Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 755 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Nov 2021to 20 Sep 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
- Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Must be able to work with smartphones/tablets/computers
Who cannot join
- 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)
- Abnormal function of the immune system resulting from clinical conditions or medication
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
- Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
North Alabama Research Center, LLC
Athens, Alabama, 35611
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
American Health Network, LLC
Charlotte, North Carolina, 28277
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Accel Research Sites
DeLand, Florida, 32720
Centennial Medical Group
Elkridge, Maryland, 21075
Be Well Clinical Studies
Lincoln, Nebraska, 68516
Pharmax Research Clinic Inc
Miami, Florida, 33126
Suncoast Research Group
Miami, Florida, 33135
Suncoast Research Associates, LLC
Miami, Florida, 33173
Clinical Research Consulting
Milford, Connecticut, 06460
Hope Research Institute
Phoenix, Arizona, 85023
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, 35216
About this study
Official title: A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
- Conditions
- Respiratory Syncytial Virus Prevention
- Being tested
- Ad26.RSV.PreF-based Vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot). Receives: Biological: Ad26.RSV.PreF-based Vaccine |
| Group 2: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1). Receives: Biological: Ad26.RSV.PreF-based Vaccine |
| Group 3: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2). Receives: Biological: Ad26.RSV.PreF-based Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Measured: 14 days post vaccination on Day 1 (Day 15)
Secondary outcomes (6)
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Measured: 14 days post vaccination on Day 1 (Day 15)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
Number of participants with solicited local AEs 7 days post vaccination 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 were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. 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 Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
Number of participants with solicited systemic AEs 7 days post vaccination 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 include events such as fatigue, headache, nausea, myalgia, and pyrexia, 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 Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
Number of participants with unsolicited AEs 28 days post vaccination 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 post vaccination on Day 1 (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
Number of participants with SAEs until 6 months post vaccination 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. An 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 6 months post vaccination on Day 1 (up to Day 183)
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
Number of participants with AESIs until 6 months post vaccination 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Measured: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021
- Primary completion28 Mar 2022
- Study completion20 Sep 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 Respiratory Syncytial Virus 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
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101486
- Sponsor's protocol ID
- CR109069
- Other IDs
- 2021-002388-23, VAC18193RSV3003
- Status last verified
- May 2025
- First submitted
- 29 Oct 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
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 Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
- ClinicalTrials.gov ID
- NCT05101486
- Acronym / sponsor ID
- CR109069
- Conditions
- Respiratory Syncytial Virus Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 6 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ad26.RSV.PreF-based Vaccine | Experimental | Biological: Ad26.RSV.PreF-based VaccineParticipants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot). |
| Group 2: Ad26.RSV.PreF-based Vaccine | Experimental | Biological: Ad26.RSV.PreF-based VaccineParticipants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1). |
| Group 3: Ad26.RSV.PreF-based Vaccine | Experimental | Biological: Ad26.RSV.PreF-based VaccineParticipants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
- Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Key exclusion criteria (6 listed)
- 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)
- Abnormal function of the immune system resulting from clinical conditions or medication
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
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: Ad26.RSV.PreF-based Vaccine, Group 2: Ad26.RSV.PreF-based Vaccine, Group 3: Ad26.RSV.PreF-based Vaccine |
Primary outcome
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
Time frame: 14 days post vaccination on Day 1 (Day 15)
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
6 secondary outcomes
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
Time frame: 14 days post vaccination on Day 1 (Day 15)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
Time frame: Up to 28 days post vaccination on Day 1 (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Results and safety
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 Volunteers
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ad26.RSV.PreF-based Vaccine in people with Respiratory Syncytial Virus Prevention, run by Janssen Vaccines & Prevention B.V. at 13 sites 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 6 inclusion and 6 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 13 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 6 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 Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination (time frame: 14 days post vaccination on Day 1 (Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.