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Trial · NCT02485301

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Subjects With Solicited Local Adverse EventsDuring the 7-Day (Days 0-6) post-vaccination period
The analysis was performed on the Total Vaccinated Cohort - Adverse Event (AE) and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Subjects With Solicited General Adverse EventsDuring the 7-Day (Days 0-6) post-vaccination period
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Subjects With Unsolicited Adverse Events (AEs)During the 30-Day (Days 0-29) post-vaccination periodThe analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Screening
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Day 3
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Day 6
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Day 30
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Month 6
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Month 6 + 6 Days
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Month 6 + 30 Days
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Haematological Laboratory AbnormalitiesAt Month 12
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Screening
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Day 3
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Day 6
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Day 30
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Month 6
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Month 6 + 6 Days
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Month 6 + 30 Days
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.
Percentage of participantsNUMBER
PRIMARYPercentage of Subjects With Biochemical Laboratory AbnormalitiesAt Month 12
The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.
Percentage of participantsNUMBER
PRIMARYNumber of Subjects With Adverse Events of Specific Interest (AESI)During the 7-Day (Days 0-6) post-vaccination periodThe analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.ParticipantsCOUNT_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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