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Adenovirus serotype 26-based respiratory syncytial virus. preF

Phase 3

Respiratory Syncytial Viruses | Monoclonal antibody | Infectious Disease |Johnson & Johnson|Last Updated: Nov 13, 2025

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment25,236

FDA Designations

No designations recorded

Clinical trial landscape

Adenovirus serotype 26-based respiratory syncytial virus. preF · 1 trial · 2 indications

Phase 3 1
NCT04908683A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and OlderRespiratory Syncytial Viruses
COMPLETED25,236 Analytics
PHASE3COMPLETED
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Respiratory Syncytial VirusesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
From Baseline (Day 1) up to 12 months

Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing).

Secondary Endpoints

Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
From Baseline (Day 1) up to 12 months
Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
From Month 12 up to Month 24
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
From Month 12 up to Month 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: Respiratory Syncytial Virus (RSV) vaccineEXPERIMENTALAll participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Group 2: PlaceboPLACEBO_COMPARATORAll participants in the placebo group will receive a single IM injection of matching placebo on Day 1.

Interventions

NameTypeDescription
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preFBIOLOGICALParticipants will receive a single IM injection of an RSV vaccine.
PlaceboBIOLOGICALParticipants will receive a single IM injection of matching placebo.
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites272

Inclusion Criteria: * Must be able to work with smartphones/tablets/computers * From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood * Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator d...

Countries:United StatesAustraliaBrazilCanadaChileChinaEstoniaFinlandNew ZealandPolandSouth AfricaTaiwanThailandUnited Kingdom
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