Trial · NCT01218308
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | subjects | NUMBER |
| SECONDARY | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | subjects | NUMBER |
| SECONDARY | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | fold increase | MEAN |
| SECONDARY | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains | On Day 0 and at least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. | At least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Subjects | NUMBER |
| SECONDARY | Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. | At Day 0 and at least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Subjects | NUMBER |
| SECONDARY | Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. | At least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Fold increase | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | During the 7-day (Days 0-6) follow-up period after any vaccination | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. | During the 7-day (Days 0-6) follow-up period after any vaccination | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. | During the 7-day (Days 0-6) follow-up period after any vaccination | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 28-day (Days 0-27) follow-up period after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs). | During the entire study period (Day 0 - Day 180) | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). | During the entire study period (Day 0 - Day 180) | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | During the entire study period (Day 0 - Day 180) | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | subjects | NUMBER |
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/NCT01218308/outcomes