Trial · NCT03110770
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Laboratory Measures of Safety (Part A) | Day 0 after first product administration through Day 112 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Laboratory Measures of Safety (Part B) | Day 0 after first product administration through Day 308 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A) | Day 0 through Day 224 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B) | Day 0 through Day 672 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A) | Day 0 through Day 224 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B) | Day 0 through Day 672 | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B) | Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and B | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Day 0 through Day 672 | All randomized participants in the study, analyzed according to the randomized study product. One placebo participant, who had a virologically confirmed case of ZIKV from a sample collected prior to first product administration, is not counted as a virologically confirmed case. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A) | Day 0 to 28 days after the third product administration | All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze. | titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A) | Day 0 to 28 days after the third product administration | All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Subclinical Cases of ZIKV (Part B Only) | Day 0 through Day 672 | All randomized participants in the study, analyzed according to the randomized study product. One placebo participant had a subclinical case of ZIKV from a sample collected prior to first product administration. Two placebo participants had subclinical cases of ZIKV but also reported symptomatic ZIKV cases close in time to the positive subclinical result, consistent with a clinical picture of one symptomatic ZIKV infection event for each. These 3 are not counted as subclinical cases. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B) | Day 0 to 28 days after the third product administration | Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power. | titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B) | Day 0 to 28 days after the third product administration | Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power. | 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.
For software
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