Trial · NCT06087640
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season) | ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction |
| Secondary | Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | |
| Secondary | Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | |
| Secondary | Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | |
| Secondary | Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | CDC = Centers for Disease Control and Prevention |
| Secondary | Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | WHO = World Health Organization |
| Secondary | Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition | From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) | |
| Secondary | Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains | Day 1 and Day 22 | |
| Secondary | Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains | Day 1 and Day 22 | |
| Secondary | Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains | Day 1 and Day 22 | Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer. |
| Secondary | Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains | Day 1 and Day 22 | |
| Secondary | Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination | Day 1 | |
| Secondary | Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period | Day 1 to Day 181 or the end of the influenza season, whichever is longer | |
| Secondary | Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period | Day 1 to Day 181 or the end of the influenza season, whichever is longer | |
| Secondary | Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period | Day 1 to Day 181 or the end of the influenza season, whichever is longer |
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/NCT06087640/registered