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CompletedNCT05101486Updated May 25, 2025Results posted

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 interventional study of Ad26.RSV.PreF-based Vaccine in Respiratory Syncytial Virus Prevention, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 13 sites in United States. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
755
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Syncytial Virus Prevention
03

In context

Lead sponsor

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.

Browse Janssen Vaccines & Prevention B.V. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Before randomization, a participant must be: a) (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, , 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 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

Exclusion criteria

Exclusion Criteria:

  • Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their (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 or 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
Terms in these criteria, in plain language(6)

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.

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).

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
755 participants (actual)

Study arms

  • Experimental
    Group 1: Ad26.RSV.PreF-based Vaccine

    Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).

    Biological: Ad26.RSV.PreF-based Vaccine

  • Experimental
    Group 2: Ad26.RSV.PreF-based Vaccine

    Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).

    Biological: Ad26.RSV.PreF-based Vaccine

  • Experimental
    Group 3: Ad26.RSV.PreF-based Vaccine

    Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).

    Biological: Ad26.RSV.PreF-based Vaccine

Interventions

  • BiologicalAd26.RSV.PreF-based Vaccine

    Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 days post vaccination on Day 1 (Day 15)

Secondary outcomes

  1. 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.

    Time frame: 14 days post vaccination on Day 1 (Day 15)

  2. 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).

    Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)

  3. 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).

    Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)

  4. 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.

    Time frame: Up to 28 days post vaccination on Day 1 (up to Day 29)

  5. 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.

    Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

  6. 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.

    Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

07

Results

Posted Sep 6, 2023

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Started251252252
Vaccinated (full analysis set [fas])250251251
Completed231241228
Not completed201124
Withdrew: Death101
Withdrew: Lost to follow-up12817
Withdrew: Physician decision100
Withdrew: Protocol violation001
Withdrew: Withdrawal by subject524
Withdrew: Randomized but not vaccinated111

Outcome measures

PrimaryGeometric 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.

Time frame:
14 days post vaccination on Day 1 (Day 15)
Reported as:
Geometric mean · ELISA units per liter (EU/L)
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
ELISA units per liter (EU/L)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination4277 (3891 to 4701)4121 (3722 to 4562)4602 (4154 to 5099)
SecondaryRespiratory 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.

Time frame:
14 days post vaccination on Day 1 (Day 15)
Reported as:
Geometric mean · Titers
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
TitersGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination6516 (5834 to 7278)5538 (4937 to 6212)6846 (6035 to 7766)
SecondaryNumber 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).

Time frame:
Up to Day 7 post vaccination on Day 1 (up to Day 8)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
ParticipantsGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination11910381
SecondaryNumber 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).

Time frame:
Up to Day 7 post vaccination on Day 1 (up to Day 8)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
ParticipantsGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination1018665
SecondaryNumber 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.

Time frame:
Up to 28 days post vaccination on Day 1 (up to Day 29)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
ParticipantsGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination221615
SecondaryNumber 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.

Time frame:
From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
ParticipantsGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination547
SecondaryNumber 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.

Time frame:
From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
ParticipantsGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination000

Adverse events

Collected over From Day 1 until 6 months post vaccination (up to Day 183). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg1/250 (0.4%)5/250 (2%)0/250 (0%)
Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg0/251 (0%)4/251 (1.6%)0/251 (0%)
Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg1/251 (0.4%)7/251 (2.8%)0/251 (0%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventGroup 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg
PneumoniaInfections and infestations2/2500/2510/251
Abdominal PainGastrointestinal disorders1/2500/2510/251
DeathGeneral disorders1/2500/2510/251
Drug Withdrawal SyndromeGeneral disorders1/2500/2510/251
CellulitisInfections and infestations1/2500/2510/251
Ankle FractureInjury, poisoning and procedural complications1/2500/2510/251
HypokalaemiaMetabolism and nutrition disorders1/2500/2510/251
HyponatraemiaMetabolism and nutrition disorders1/2500/2510/251
Peroneal Nerve PalsyNervous system disorders1/2500/2510/251
Cardiac ArrestCardiac disorders0/2500/2511/251

Baseline characteristics

The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.

Age, Continuous
Age, Continuous(years)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcgTotal
Mean65.7 ± 4.3765.5 ± 4.4265.5 ± 4.2765.6 ± 4.35
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcgTotal
Female127145144416
Male123106107336
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcgTotal
Hispanic or Latino150144144438
Not Hispanic or Latino98105105308
Unknown or Not Reported2226
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcgTotal
American Indian or Alaska Native1001
Asian0112
Native Hawaiian or Other Pacific Islander0000
Black or African American394241122
White209206207622
More than one race0123
Unknown or Not Reported1102
Region of Enrollment
Region of Enrollment(Participants)Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcgGroup 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcgGroup 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcgTotal
UNITED STATES250251251752
08

Study locations

13 sites
  • North Alabama Research Center, LLC
    Athens, Alabama 35611, United States
  • Achieve Clinical Research, LLC
    Vestavia Hills, Alabama 35216, United States
  • Hope Research Institute
    Phoenix, Arizona 85023, United States
  • Clinical Research Consulting
    Milford, Connecticut 06460, United States
  • Accel Research Sites
    DeLand, Florida 32720, United States
  • Pharmax Research Clinic Inc
    Miami, Florida 33126, United States
  • Suncoast Research Group
    Miami, Florida 33135, United States
  • Suncoast Research Associates, LLC
    Miami, Florida 33173, United States
  • Atlanta Center for Medical Research
    Atlanta, Georgia 30331, United States
  • Centennial Medical Group
    Elkridge, Maryland 21075, United States
  • Be Well Clinical Studies
    Lincoln, Nebraska 68516, United States
  • American Health Network, LLC
    Charlotte, North Carolina 28277, United States
  • CTI Clinical Trial and Consulting Services
    Cincinnati, Ohio 45212, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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

Data sharing details ↗ · www.janssen.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05101486
Lead sponsor
Janssen Vaccines & Prevention B.V.
Responsible party
Sponsor
First posted
Nov 1, 2021
Start date
Nov 1, 2021
Primary completion
Mar 28, 2022
Completion
Sep 20, 2022
Results posted
Sep 6, 2023
Last update
May 25, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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