Trial · NCT03982199
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| SECONDARY | Revaccination Subcohorts: Number of Participants With Solicited Local AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years | Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102) | The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Revaccination Subcohorts: Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years | Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102) | The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Revaccination Subcohorts: Number of Participants With Unsolicited AEs 28 Days After Re-vaccination up to 1, 2 and 3 Years | Arms 3,4: 28 days after revacc at 1 year (up to Day 393); Arms 5,6,7,8,9: 28 days after revacc at 2 years (up to Day 758); Arms 10,11,12,13,14: 28 days after revaccination at 3 year (up to Day 1123) | The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Revaccination Subcohorts: Number of Participants With Adverse Events of Special Interests (AESI) | Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277) | The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Cohorts:Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Day 1095 | The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Revaccination Subcohorts: Number of Participants With Serious Adverse Events (SAEs) | Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277) | The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Cohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Days 15, 85, 169, 365, 533 | PPI: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed)=participants who were evaluable for this outcome measure, n=participants evaluable for specific timepoints. | Titers | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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