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Trial · NCT04024228

Outcomes14

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYGeometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 YearsDay 28 post-vaccinationAnalysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.titersGEOMETRIC_MEAN
SECONDARYGeometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group ParticipantsDay 0 (pre-vaccination), Day 28 (post-vaccination)Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.titersGEOMETRIC_MEAN
SECONDARYGeometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 YearsDay 0 (pre-vaccination), Day 28 (post-vaccination)Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.titersGEOMETRIC_MEAN
SECONDARYGeometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group ParticipantsDay 0 (pre-vaccination), Day 28 (post-vaccination)Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.ratioGEOMETRIC_MEAN
SECONDARYGeometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 YearsDay 0 (pre-vaccination), Day 28 (post-vaccination)Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.ratioGEOMETRIC_MEAN
SECONDARYPercentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)Day 28 post-vaccinationAnalysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.percentage of participantsNUMBER
SECONDARYPercentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution)Day 28 post-vaccinationAnalysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.percentage of participantsNUMBER
SECONDARYPercentage of Participants (All Age Group Participants) Achieving Seroconversion Against AntigensDay 28 post-vaccinationAnalysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.percentage of participantsNUMBER
SECONDARYPercentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against AntigensDay 28 post-vaccinationAnalysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.percentage of participantsNUMBER
SECONDARYNumber of Participants Reporting Immediate Unsolicited Adverse Events (AEs)Within 30 minutes post-vaccinationAnalysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Solicited Injection Site ReactionsWithin 7 days post-vaccinationAnalysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Solicited Systemic ReactionsWithin 7 days post-vaccinationAnalysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Unsolicited Adverse Events (AEs)Within 28 days post-vaccinationAnalysis was performed on SafAS population.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)From Day 0 up to 6 months post-vaccinationAnalysis was performed on the SafAS population.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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