Trial · NCT07890454
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antibody titers against for each of the 3 influenza vaccine strains(in a subset of participants) | At Day 28 after vaccination | Geometric mean (GMT) of antibody titers measured by hemagglutination inhibition (HAI) |
| Primary | Antibody titers against SARS-CoV-2 specific variant(in a subset of participants) | At Day 28 after vaccination | Geometric mean (GMT) of antibody titers measured by pseudovirus neutralization test (PNT) |
| Secondary | Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants) | Up to 8 each days after vaccination | Number of participants with solicited injection site reactions pre-listed in the participant diary and case report form (CRF) |
| Secondary | Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants) | Up to 8 each days after vaccination | Number of participants with solicited systemic reactions pre-listed in the participant diary and case report form (CRF) |
| Secondary | Presence of immediate adverse events after vaccination | Within the 30 minutes after vaccination | Number of participants with immediate adverse events (AEs). Immediate adverse events are any unsolicited systemic adverse events within 30 minutes after vaccination |
| Secondary | Presence of unsolicited adverse events | Up to 28 days after vaccination | Number of participants with unsolicited adverse events (AEs) for 28 days, including the day of vaccination |
| Secondary | Presence of all medically attended adverse events | Up to 180 days after vaccination | Number of participants with medical attended adverse events (MAAEs) for 180 days, including the day of vaccination |
| Secondary | Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases | From Day 181 through 12 months following study vaccination | Number of participants with medical attended adverse events (MAAEs) linked to predefined potential immune-mediated diseases (PIMDs) following the study vaccination |
| Secondary | Presence of all adverse events of special interest | Up to 180 days after vaccination | Number of participants with adverse events of special interest (AESIs) for 180 days, including the day of vaccination |
| Secondary | Presence of all serious adverse events | Up to 180 days after vaccination | Number of participants with serious adverse events (SAEs) for 180 days, including the day of vaccination |
| Secondary | Presence of related serious adverse events | From Day 181 through 12 months following study vaccination | Number of participants with serious adverse events (SAEs) from D181 through 12 months following the last study vaccination |
| Secondary | Presence of related adverse events of special interest | From Day 181 through 12 months following study vaccination | Number of participants with adverse events of special interest (AESIs) from D181 through 12 months following the last study vaccination |
| Secondary | Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events | From Day 181 through 12 months following study vaccination | Number of patients with medical attended adverse events (MAAES) linked to predefined potential immune-mediated diseases (PIMDs) meets criteria for serious adverse events (SAEs) from D181 through 12 months following the last study vaccination |
| Secondary | Presence of adverse events leading to study discontinuation throughout the study | From Day 01 through 12 months | Number of participants with adverse events lead to study discontinuation |
| Secondary | Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains | At Day 29 | Percentage of participants Seroconversion is defined by: pre-injection antibody titer \< 10 \[1/dil\] at D01 and post-injection antibody titer ≥ 40 \[1/dil\] at D29, or pre-injection antibody titer ≥ 10 \[1/dil\] at D01 and a ≥ 4-fold increase in titer at D29 |
| Secondary | SARS-CoV-2 seroresponse status after vaccination | At Day 29 | Percentage of participantsSeroresponse to SARS-CoV-2 is defined by: pre-injection antibody titer \< LLOQ \[1/dil\] and post-injection antibody titer ≥ 4\*LLOQ \[1/dil\] at D29, or pre-injection antibody titer ≥ LLOQ \[1/dil\] at D01 and a ≥ 4-fold increase in titer \[1/dil\] at D29 |
| Secondary | Neutralizing antibody titers measured by neutralization test (NT) against each of the 3 influenza vaccine strains before and after vaccination (in a subset of participants) | At Day 01 and Day 29 | Neutralizing antibody titers \[1/dil\] |
| Secondary | Individual neutralizing antibody titer ratio measured by neutralization test NT against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) | At Day 01 and Day 29 | Individual neutralizing titers ratio Day 29/Day 01 |
| Secondary | Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination(in a subset of participants) | At Day 29 | Percentage of participants with neutralization test (NT) titer ≥ 10 (1/dil) |
| Secondary | Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) | At Day 29 | Percentage of participants with neutralization test (NT) titer ≥ 20 (1/dil) |
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/NCT07890454/registered