A Phase 3 interventional study of Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF and Placebo in Respiratory Syncytial Viruses and Lower Respiratory Tract Disease, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 272 sites in 14 countries. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
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.
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.
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).
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Biological: Placebo
Participants will receive a single IM injection of an RSV vaccine.
Participants will receive a single IM injection of matching 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)
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).
Time frame: From Baseline (Day 1) up to 12 months
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: From Month 12 up to Month 24
Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
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.
Time frame: Baseline (Day 1) up to 24 months
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: 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 Adverse Events of Special Interest (AESIs)
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.
Time frame: 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 Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
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.
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
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).
Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Unsolicited AEs up to 28 Days After Vaccination
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.
Time frame: Up to 28 days post vaccination on Day 1 (up to Day 29)
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization 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.
Time frame: At 14 Days post vaccination on Day 1 (Day 15)
Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination
GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
Time frame: At 14 days post vaccination on Day 1 (Day 15)
T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
Time frame: 14 days post vaccination on Day 1 (Day 15)
Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). 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. RiiQ total Symptom score was the mean of all scores (based on 13 symptoms). The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.
Time frame: Baseline (Day 1) up to 24 months
| Milestone | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Started | 16817 | 8419 |
| Randomized and vaccinated | 16709 | 8367 |
| Completed | 124 | 59 |
| Not completed | 16693 | 8360 |
| Withdrew: Failure to meet continuation criteria | 34 | 22 |
| Withdrew: Initiated prohibited medication | 3 | 0 |
| Withdrew: Randomized by mistake | 1 | 0 |
| Withdrew: Lost to follow-up | 679 | 341 |
| Withdrew: Participant met eligibility criteria but were not needed | 3 | 1 |
| Withdrew: Physician decision | 44 | 35 |
| Withdrew: Technical problems | 12 | 9 |
| Withdrew: Withdrawal by legally authorized representative | 1 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Withdrawal by subject | 1188 | 570 |
| Withdrew: Site closure by sponsor | 6 | 3 |
| Withdrew: Adverse event | 21 | 11 |
| Withdrew: Death | 101 | 61 |
| Withdrew: Sponsor's decision | 14398 | 7205 |
| Withdrew: Other | 92 | 50 |
| Withdrew: Randomized not vaccinated | 108 | 52 |
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).
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | 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) | 44 | 63 |
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).
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI) | 77 | 101 |
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).
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year | 16 | 29 |
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).
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year | 39 | 44 |
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.
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | 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 | 4 | 11 |
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.
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| 28 days post vaccination on Day 1 | 119 | 53 |
| First year follow-up | 446 | 239 |
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.
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| 28 days post vaccination on Day 1 | 25 | 4 |
| First year follow-up | 71 | 35 |
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.
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination | 1076 | 169 |
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).
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination | 1018 | 236 |
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.
| Participants | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Number of Participants With Unsolicited AEs up to 28 Days After Vaccination | 554 | 206 |
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
| Titers | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination | 7194 (6394 to 8093) | 537 (455 to 634) |
GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
| Titers | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination | 4932 (4477 to 5433) | 410 (348 to 484) |
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
| SFC/10^6 PBMCs | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | 533 (306 to 873) | NA (NA to 78) |
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). 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. RiiQ total Symptom score was the mean of all scores (based on 13 symptoms). The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.
| Scores on a scale*hours | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score | 82 (21 to 141) | 107 (48 to 218) |
Collected over From Day 1 up to 24 months post-vaccination on Day 1 (Day 731).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Ad26.RSV.preF and RSV preF Protein | 105/16,709 (0.6%) | 842/16,709 (5%) | 1,477/2,330 (63.4%) |
| Group 2: Placebo | 61/8,367 (0.7%) | 457/8,367 (5.5%) | 408/1,165 (35%) |
| Event | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 46/16709 | 26/8367 |
| DeathGeneral disorders | 18/16709 | 18/8367 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 31/16709 | 14/8367 |
| Covid-19Infections and infestations | 29/16709 | 12/8367 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 29/16709 | 9/8367 |
| Atrial FibrillationCardiac disorders | 24/16709 | 13/8367 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 16/16709 | 13/8367 |
| Myocardial InfarctionCardiac disorders | 23/16709 | 12/8367 |
| Coronary Artery DiseaseCardiac disorders | 14/16709 | 11/8367 |
| Transient Ischaemic AttackNervous system disorders | 15/16709 | 11/8367 |
| Event | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo |
|---|---|---|
| Vaccination Site Pain(Solicited)General disorders | 1065/2330 | 168/1165 |
| Fatigue(Solicited)General disorders | 789/2330 | 165/1165 |
| Myalgia(Solicited)Musculoskeletal and connective tissue disorders | 614/2330 | 119/1165 |
| Headache(Solicited)Nervous system disorders | 597/2330 | 128/1165 |
| Nausea(Solicited)Gastrointestinal disorders | 324/2330 | 75/1165 |
| Pyrexia(Solicited)General disorders | 171/2330 | 5/1165 |
| Blood Pressure Systolic IncreasedInvestigations | 150/2330 | 60/1165 |
| Respiratory Rate IncreasedInvestigations | 89/2330 | 49/1165 |
| Vaccination Site Swelling(Solicited)General disorders | 68/2330 | 3/1165 |
| CoughRespiratory, thoracic and mediastinal disorders | 68/2330 | 25/1165 |
Baseline characteristics data were analyzed on full analysis set (FAS) which included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
| Age, Continuous(years) | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo | Total |
|---|---|---|---|
| Mean | 70.2 ± 5.24 | 70.2 ± 5.23 | 70.2 ± 5.24 |
| Age, Customized(Participants) | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo | Total |
|---|---|---|---|
| Adults (60-64 years) | 1472 | 740 | 2212 |
| From 65 to 84 years | 15053 | 7534 | 22587 |
| 85 years and over | 184 | 93 | 277 |
| Sex/Gender, Customized(Participants) | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo | Total |
|---|---|---|---|
| Female | 9063 | 4452 | 13515 |
| Male | 7645 | 3913 | 11558 |
| Others | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1555 | 741 | 2296 |
| Not Hispanic or Latino | 14903 | 7496 | 22399 |
| Unknown or Not Reported | 251 | 130 | 381 |
| Race (NIH/OMB)(Participants) | Group 1: Ad26.RSV.preF and RSV preF Protein | Group 2: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 58 | 17 | 75 |
| Asian | 1757 | 897 | 2654 |
| Native Hawaiian or Other Pacific Islander | 98 | 49 | 147 |
| Black or African American | 1820 | 935 | 2755 |
| White | 12649 | 6297 | 18946 |
| More than one race | 189 | 101 | 290 |
| Unknown or Not Reported | 138 | 71 | 209 |
Showing the first 100 of 272 sites across 14 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
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
Ran from Jul 2021 to primary completion in Jul 2023, 24 months.
Results were first posted in Feb 2024, 6 months after primary completion.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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