Trial · NCT01162122
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | Day 22 post vaccination | Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS | Day 22 post vaccination | Analysis was done on PPS. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Percentage of subjects | NUMBER |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS) | Day 22 post vaccination | Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22 | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS | Day 22 post vaccination | Analysis was done on FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With HI Titers ≥40 Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Percentage of subjects | NUMBER |
| SECONDARY | Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS | Day 22 post vaccination | Analysis was done on FAS population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| SECONDARY | Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS | Day 22 postvaccination | Analysis was done on FAS. | Percentage of subjects | NUMBER |
| SECONDARY | Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS | Day 22 post vaccination | Analysis was done on FAS. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS | Day 22 postvaccination | Analysis was done on PPS. | Percentage of subjects | NUMBER |
| SECONDARY | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS | Day 22 post vaccination | Analysis was done on FAS | Percentage of subjects | NUMBER |
| SECONDARY | Persistence of GMTs Against Homologous and Heterologous Strains | Day 181, Day 366 post vaccination | The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366. | Titers | GEOMETRIC_MEAN |
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/NCT01162122/outcomes