Trial · NCT06060457
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection | Within 7 days after Day 1 injection | Day 1 Solicited Safety Set included all randomized participants who received any study intervention on Day 1 and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection | Within 7 days after Day 22 injection | Day 22 Solicited Safety Set included all randomized participants who received any study intervention on Day 22 and contributed any solicited ARs data from the time of study injection on Day 22 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection | Up to 21 days after Day 1 injection | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection | Up to 21 days after Day 22 injection | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Day 1 through Day 202 | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs) | Day 22 (for Arm 1) and Day 43 (for Arm 2) | The Per-protocol (PP) Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 22 | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | titer | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay | Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay | Day 22 (for Arm 1) or Day 43 (for Arm 2) | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs | Day 22 (Arm 1) or Day 43 (Arm 2) | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion, as Measured by HAI Assay | Day 22 | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | GMFR of Serum Ab Level, as Measured by HAI Assay | Day 22 | The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | ratio | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Number of Deaths Related to Study Drug | Day 1 through Day 202 | The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06060457/outcomes