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Trial · NCT04546724

Outcomes15

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With a Seroprotective CHIKV Antibody Level for Baseline Negative Subjects 28 Days Post-vaccinationon Day 29 after single vaccinationThe Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYCHIKV-specific Neutralizing Antibody TitersUntil Day 180The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.Antibody TitersGEOMETRIC_MEAN
SECONDARYNumber of Participants With Seroprotective CHIKV Antibody LevelUntil Day 180
The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations (PDs) that could impact the immune response.~Counts of participants per time point vary: baseline AND post-line µPRNT result are needed at a given timepoint; results for a specific timepoint were excluded in case of major PD (e.g., major time window deviation resulted in exclusion of a result for a given visit/ time point, results from earlier/ later visits were included)
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With SeroconversionUntil Day 180The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFold Change of CHIKV-specific Neutralizing Antibody Titers Compared to Baselineuntil Day 180The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.fold increaseMEAN
SECONDARYNumber of Participants Reaching an X-fold Change in CHICKV-specific Neutralizing Antibody Titer Compared to Baselineuntil Day 180The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYUnsolicited AEsUntil Day 29ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSolicited Injection Site AEswithin 10 days post-vaccinationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSolicited Systemic AEswithin 10 days post-vaccinationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAdverse Eventsuntil Day 180ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRelated Adverse Eventsuntil Day 180ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSerious Adverse Eventuntil Day 180ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRelated Serious Adverse Eventuntil Day 180ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAdverse Event of Special Interestwithin 21 days post-vaccinationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRelated Adverse Event of Special Interestwithin 21 days post-vaccinationParticipantsCOUNT_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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