Trial · NCT03964415
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | From Month 7 up to Month 24 | The PP set included all participants in the full analysis set (FAS; all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | From Month 7 up to Month 30 | The PP set included all participants in the FAS (all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 6 months after the last vaccination (up to Month 18) | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically-attended Adverse Events (MAAEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24, Month 0 to 30, Month 0 to 40 | The mITT efficacy population included participants in the FAS who were HIV-1 uninfected at the date of the first vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 24, Month 7 to 30, Month 7 to 40 | The mITT-2 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 24, Month 7 to 30, Month 7 to 40 | The mITT-3 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits regardless of the fact if the vaccinations were within the visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 24, Month 13 to 30, Month 13 to 40 | The FIS included participants in the FAS who were HIV-1 uninfected 4 weeks after the fourth vaccination visit (that is, at Month 13 Visit) and who received all planned vaccinations within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24, Month 7 to 30, Month 7 to 40 | The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24, Month 7 to 30, Month 7 to 40 | The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | Baseline (Day 1) | The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the case-control analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | From Day 1 up to Month 40 | The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24, Month 7 to 30, Month 7 to 40 | The PP set included all subjects in FAS (all randomized participants who received at least one vaccine) set who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within respective visit windows. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure and 'n' (number analyzed) indicated participants analyzed at specified timepoints. | 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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GET https://conductscience.org/api/trials/v1/NCT03964415/outcomes