Trial · NCT04908683
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
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 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 |
| SECONDARY | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination | At 14 Days post vaccination on Day 1 (Day 15) | Per-protocol Immunogenicity (PPI) population included all randomized and vaccinated participants who were part of the immunogenicity subset (consisted of at least 360 participants, of whom \~50% were at increased risk for severe RSV disease and \~50% were 75 years or older) and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Titers | GEOMETRIC_MEAN |
| SECONDARY | 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 | At 14 days post vaccination on Day 1 (Day 15) | PPI population included all randomized and vaccinated participants who were part of the immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Titers | GEOMETRIC_MEAN |
| SECONDARY | T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | 14 days post vaccination on Day 1 (Day 15) | 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. | SFC/10^6 PBMCs | MEDIAN |
| SECONDARY | Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score | Baseline (Day 1) up to 24 months | PPE population includes 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. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Scores on a scale*hours | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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