Trial · NCT06028347
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions | up to 60 minutes or within 6 hours post vaccination | |
| Primary | Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs | Day 1 to Day 14 of each post vaccination period | |
| Primary | Number and percentage of subjects reporting unsolicited AEs | Day 1 to Day 43 | |
| Primary | Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs). | Day 1 to Day 202 | |
| Primary | Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values | Day 3 to Day 43 | |
| Primary | Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments | Day 3 to Day 43 | |
| Primary | Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay | Day 1, Day 22, Day 43 | |
| Primary | Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ]) | Day 1, Day 22, Day 43 | |
| Primary | Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320 | Day 1, Day 22, Day 43 | |
| Primary | Seroconversion rate (SCR) by HAI assay | Day 1, Day 22, Day 43 | SCR defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination |
| Secondary | Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay | Day 1, Day 202 | |
| Secondary | Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer | Day 1, Day 202 | |
| Secondary | Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ) | Day 202 | |
| Secondary | Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320 | Day 202 | |
| Secondary | Seroconversion rate (SCR) by HAI assay | Day 1, Day 202 | |
| Secondary | Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay | Day 1, Day 22, Day 43, Day 202 | |
| Secondary | Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer | Day 1, Day 22, Day 43, Day 202 |
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/NCT06028347/registered