Trial · NCT03982199
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
NCT03982199, Phase 2, Terminated, Janssen Vaccines & Prevention B.V.; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older. Trials, record NCT03982199. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03982199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
- NCT number
- NCT03982199
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5,815 participants, actual
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Conditions
- Respiratory Syncytial Viruses, Respiratory Tract Diseases
- Interventions
- RSV Vaccine, Placebo
- First posted
- 2019-06-11
- Last updated
- 2025-05-25
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes17
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 screening (Day 1) up to 9 months | Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (\>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in \>=2 OR \>=1 symptoms of LRTI with \>=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI (cough, shortness of breath, sputum production, wheezing and tachypnea) were collected via the RiiQ. 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 LRTD symptom scores. |
| Secondary | Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease | From screening (Day 1) up to 9 months | Number of participants with any RT-PCR-confirmed RSV disease were reported. The analysis was based on poisson regression model. |
| Secondary | Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Days 15, 85, 169, 365 | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. |
| Secondary | Revaccination Subcohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Days 15, 365, 379, 393, 449, 730, 737, 744, 758 | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. |
| Secondary | Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14 | GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported. |
| Secondary | Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Days 730, 744, 758 | T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein 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). |
| Secondary | Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Days 15, 85, 169, 365, 533 | T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein 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). |
| Secondary | Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination | Up to Day 8 (7 days after first vaccination on Day 1) | 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/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention. |
| Secondary | Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination | Up to Day 8 (7 days after first vaccination on Day 1) | 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, arthralgia, and fever (defined as an endogenous elevation of body temperature \>=38.0°C, as recorded in at least one measurement). |
| Secondary | Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination | Up to Day 29 (28 days after first vaccination on Day 1) | 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 is not specifically questioned in the participant diary. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 screening (Day 1) up to 9 months | The Per-protocol Efficacy (PPE) population included all randomized and vaccinated participants excluding participants with major protocol deviations expecting to impact the efficacy outcomes. Any participant with an RT-PCR-confirmed RSV-mediated acute respiratory infection (ARI) with 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 | Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease | From screening (Day 1) up to 9 months | The PPE population included all randomized and vaccinated participants excluding participants with major protocol deviations expecting to impact the efficacy outcomes. Any participant with an RT-PCR-confirmed RSV-mediated ARI with 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 | Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Days 15, 85, 169, 365 | Per-protocol Immunogenicity (PPI) population included all randomized and vaccinated participants who were part of the immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (participants analyzed) signifies the participants evaluable at specified timepoints. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Revaccination Subcohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Days 15, 365, 379, 393, 449, 730, 737, 744, 758 | PPI set: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. 'N' (number of participants analyzed): participants evaluable for this outcome measure, 'n' (participants analyzed): participants evaluable at specified timepoints and 'n (number analyzed)=0' signifies that none of participants were available for the assessment at specified timepoints. This outcome measure was planned to be analyzed for specified arms only. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14 | PPI set: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. 'N' (number of participants analyzed): participants evaluable for this outcome measure, 'n' (participants analyzed): participants evaluable at specified timepoints and 'n (number analyzed)=0' signifies that none of participants were available for the assessment at specified timepoints. This outcome measure was planned to be analyzed for specified arms only. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Days 730, 744, 758 | PPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 'n' signifies participants evaluable for specified timepoints. This outcome measure was planned to be analyzed for specified arms only. | SFC/10^6 PBMCs | MEDIAN |
| SECONDARY | Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Days 15, 85, 169, 365, 533 | PPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 'n' signifies participants evaluable for specified timepoints. | SFC/10^6 PBMCs | MEDIAN |
| SECONDARY | Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination | Up to Day 8 (7 days after first vaccination on Day 1) | The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination | Up to Day 8 (7 days after first vaccination on Day 1) | The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination | Up to Day 29 (28 days after first vaccination on Day 1) | The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group200
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) | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | Case Definition-1 | 6 | 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) | Arm 2: Main Cohort: Group 2: Placebo | Case Definition-1 | 30 | 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) | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | Case Definition-2 | 10 | 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) | Arm 2: Main Cohort: Group 2: Placebo | Case Definition-2 | 40 | 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) | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | Case Definition-3 | 13 | 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) | Arm 2: Main Cohort: Group 2: Placebo | Case Definition-3 | 43 | Participants | |
| Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | 13 | Participants | ||
| Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease | Arm 2: Main Cohort: Group 2: Placebo | 43 | Participants | ||
| Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | Day 15 | 6761 | 95% Confidence Interval 5478 to 8346 | Titers |
| Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Arm 2: Main Cohort: Group 2: Placebo | Day 15 | 516 | 95% Confidence Interval 443 to 602 | Titers |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 results by groupParticipant flow182
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | 2,909 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 2: Main Cohort: Group 2: Placebo | 2,906 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | |
| Main Cohorts (Day 1 up to Day 1095) | STARTED | Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF | 0 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 participant flowAdverse events4,172
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 | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | 0 | 348 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 2: Main Cohort: Group 2: Placebo | 0 | 347 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 120 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture | 0 | 126 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone | 0 | 28 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone | 0 | 28 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 28 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 137 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 149 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF | 1 | 37 |
1 to 10 of 4,172Source ClinicalTrials.gov
See all 4,172 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | 39 | 2,891 |
| Total, all-cause mortality | Arm 2: Main Cohort: Group 2: Placebo | 38 | 2,891 |
| Total, all-cause mortality | Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 1 | 120 |
| Total, all-cause mortality | Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture | 0 | 126 |
| Total, all-cause mortality | Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone | 0 | 28 |
| Total, all-cause mortality | Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone | 0 | 28 |
| Total, all-cause mortality | Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 28 |
| Total, all-cause mortality | Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 0 | 137 |
| Total, all-cause mortality | Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture) | 2 | 149 |
| Total, all-cause mortality | Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF | 0 | 37 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers2
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts:Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination | Trial comparisons |
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination | Trial comparisons |
| Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease | Trial comparisons |
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination | 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03982199
GET https://conductscience.org/api/trials/v1/NCT03982199/results?page=2