Trial · NCT04908683
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
NCT04908683, Phase 3, Completed, Janssen Vaccines & Prevention B.V.; results first posted 2024-02-08
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ConductScience Library. 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. Trials, record NCT04908683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04908683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04908683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25,236 participants, actual
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Conditions
- Respiratory Syncytial Viruses, Lower Respiratory Tract Disease
- Interventions
- Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, Placebo
- First posted
- 2021-06-01
- Last updated
- 2025-11-13
- Other registries' IDs
- eudract:2020-005458-97
- Results first posted
- 2024-02-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following protocol defined criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), 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-items 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 ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing). |
| Secondary | 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 LRTD during the second year 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 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-items 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 | 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 | A participant was considered to have RT-PCR-confirmed RSV-mediated ARI according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), 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-items 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 ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing). |
| Secondary | Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | Baseline (Day 1) up to 24 months | A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154) | Number of participants with SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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. |
| Secondary | Number of Participants With Potential Adverse Events of Special Interest (AESIs) | 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154) | Number of participants with potential AESIs were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage. |
| Secondary | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination | Up to Day 7 post vaccination on Day 1 (up to Day 8) | Number of participants with solicited local AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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 included erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration. |
| Secondary | Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination | Up to Day 7 post vaccination on Day 1 (up to Day 8) | Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, 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). |
| Secondary | Number of Participants With Unsolicited AEs up to 28 Days After Vaccination | Up to 28 days post vaccination on Day 1 (up to Day 29) | Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the participant was not specifically questioned in the subject diary. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Per-protocol efficacy (PPE) population included all randomized and vaccinated participants, excluding those with major protocol deviations (MPDs) expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year | From Month 12 up to Month 24 | PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | PPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | Baseline (Day 1) up to 24 months | PPE population is defined as population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154) | Full analysis set (FAS) included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potential Adverse Events of Special Interest (AESIs) | 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154) | FAS included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination | Up to Day 7 post vaccination on Day 1 (up to Day 8) | The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination | Up to Day 7 post vaccination on Day 1 (up to Day 8) | The safety subset (a subset of FAS) included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited AEs up to 28 Days After Vaccination | Up to 28 days post vaccination on Day 1 (up to Day 29) | The safety subset (a subset of FAS) included all participants that consented to the collection of AEs (unsolicited AEs for 28 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Group 1: Ad26.RSV.preF and RSV preF Protein | 44 | Participants | ||
| 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) | Group 2: Placebo | 63 | Participants | ||
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI) | Group 1: Ad26.RSV.preF and RSV preF Protein | 77 | Participants | ||
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI) | Group 2: Placebo | 101 | Participants | ||
| Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year | Group 1: Ad26.RSV.preF and RSV preF Protein | 16 | Participants | ||
| Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year | Group 2: Placebo | 29 | Participants | ||
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year | Group 1: Ad26.RSV.preF and RSV preF Protein | 39 | Participants | ||
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year | Group 2: Placebo | 44 | Participants | ||
| Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | Group 1: Ad26.RSV.preF and RSV preF Protein | 4 | Participants | ||
| Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | Group 2: Placebo | 11 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Ad26.RSV.preF and RSV preF Protein | 16,817 | |
| Overall Study | STARTED | Group 2: Placebo | 8,419 | |
| Overall Study | Randomized and Vaccinated | Group 1: Ad26.RSV.preF and RSV preF Protein | 16,709 | |
| Overall Study | Randomized and Vaccinated | Group 2: Placebo | 8,367 | |
| Overall Study | COMPLETED | Group 1: Ad26.RSV.preF and RSV preF Protein | 124 | |
| Overall Study | COMPLETED | Group 2: Placebo | 59 | |
| Overall Study | NOT COMPLETED | Group 1: Ad26.RSV.preF and RSV preF Protein | 16,693 | |
| Overall Study | NOT COMPLETED | Group 2: Placebo | 8,360 |
Source ClinicalTrials.gov
Adverse events1,204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea(Solicited) | Gastrointestinal disorders | Group 1: Ad26.RSV.preF and RSV preF Protein | 324 | 2,330 | 324 |
| other | Nausea(Solicited) | Gastrointestinal disorders | Group 2: Placebo | 75 | 1,165 | 75 |
| other | Fatigue(Solicited) | General disorders | Group 1: Ad26.RSV.preF and RSV preF Protein | 789 | 2,330 | 789 |
| other | Fatigue(Solicited) | General disorders | Group 2: Placebo | 165 | 1,165 | 165 |
| other | Pain | General disorders | Group 1: Ad26.RSV.preF and RSV preF Protein | 48 | 2,330 | 61 |
| other | Pain | General disorders | Group 2: Placebo | 12 | 1,165 | 18 |
| other | Pyrexia(Solicited) | General disorders | Group 1: Ad26.RSV.preF and RSV preF Protein | 171 | 2,330 | 171 |
| other | Pyrexia(Solicited) | General disorders | Group 2: Placebo | 5 | 1,165 | 5 |
| other | Vaccination Site Erythema(Solicited) | General disorders | Group 1: Ad26.RSV.preF and RSV preF Protein | 63 | 2,330 | 63 |
| other | Vaccination Site Erythema(Solicited) | General disorders | Group 2: Placebo | 5 | 1,165 | 5 |
1 to 10 of 1,204Source ClinicalTrials.gov
See all 1,204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Ad26.RSV.preF and RSV preF Protein | 105 | 16,709 |
| Total, all-cause mortality | Group 2: Placebo | 61 | 8,367 |
| Total, other adverse events | Group 1: Ad26.RSV.preF and RSV preF Protein | 1,477 | 2,330 |
| Total, other adverse events | Group 2: Placebo | 408 | 1,165 |
| Total, serious adverse events | Group 1: Ad26.RSV.preF and RSV preF Protein | 842 | 16,709 |
| Total, serious adverse events | Group 2: Placebo | 457 | 8,367 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI) | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year | Trial comparisons |
Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: 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) | Trial comparisons |
Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: deaths from any cause | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With Unsolicited AEs up to 28 Days After Vaccination | Trial comparisons |
| Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT04908683/results?page=2