Trial · NCT03165617
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| PRIMARY | Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses) | FAS Immunogenicity - All Subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline at after the last vaccination | Geometric mean titers (GMTs) | NUMBER |
| SECONDARY | ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay) | Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) | FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Percentage of participants | NUMBER |
| SECONDARY | Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay) | Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses) | FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Geometric mean ratio (GMR) | NUMBER |
| SECONDARY | Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all previously vaccinated subjects receiving a single vaccine dose) or Days 29 and 50 (all not previously vaccinatedsubjects receiving 2 doses) | Dataset used: FAS Immunogenicity = all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Percentage of participants | NUMBER |
| SECONDARY | Safety: Percentage of Subjects With Solicited Local and Systemic Adverse Events for 7 Days After Vaccination | days after vaccination on Day 1 (for previously vaccinated subjects) or for 7 days after vaccination on Day 1 and Day 29 (for not previously vaccinated subjects) | Dataset used: Solicited Safety Set = All subjects in the Exposed Set who had gone through any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics.~Note: Other solicited adverse events refer to use of analgesics / antipyretics for prophylaxis or treatment. | Percentage of participants | NUMBER |
| SECONDARY | Safety: Percentage of Subjects With Unsolicited AEs for 21 Days After Vaccination | Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects) | Dataset used: unsolicited Safety Set defined as all subjects in the Exposed Set who had gone through any AE assessments, ie, a subject did not have to have any AEs to be included in this population | Percentage of participants | NUMBER |
| SECONDARY | Safety: Subjects With SAEs, AEs Leading to Withdrawal From Vaccination and/or the Study,(MAAEs) Within 30 Days of a 1st Occurrence, Post-ILI, and NOCDs Reported During Entire Study Participation or End of Flue Season, Whichever Was Longer | Day 1 to Day 181 (for previously vaccinated subjects) or to Day 209 (for not previously vaccinated subjects) | Dataset used: overall safety set defined as all subjects in the Solicited Safety Set and/or Unsolicited Safety Set. Subjects providing only 30 minutes postvaccination safety data were also reported separately in a 30-minute postvaccination safety analysis. | Percentage of participants | 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.
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