Trial · NCT00980005
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | At Day 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | At Day 0 and at Day 28 after last vaccine dose | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Fold change | MEAN |
| SECONDARY | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and at Day 28 after last vaccine dose | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Fold change | MEAN |
| SECONDARY | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | During a 28 day follow-up period (Days 0-27) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | During a 28 day follow-up period (Days 0-27) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | During the entire study period (From Day 0 up to Day 180). | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Serious Adverse Events (SAEs). | During the entire study period (From Day 0 up to Day 180). | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
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.
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