Trial · NCT03060629
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Month 7 up to Month 24 | Per protocol (PP) population set included participants from the full analysis set (FAS; all randomized participants who received at least one study vaccine administration) who were HIV-1 uninfected 4 weeks after the third vaccination visit, who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows and had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 30 days after first vaccination on Day 0 (Up to Day 30) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | 30 days after second vaccination on Day 84 (Up to Day 114) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | 30 days after third vaccination on Day 168 (Up to Day 198) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | 30 days after fourth vaccination on Day 364 (Up to Day 394) | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) | Up to Month 36 (up to end of the study) | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Up to Month 36 (up to end of the study) | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | Up to Month 36 (up to end of the study) | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Baseline up to Month 24 | Modified Intent-to-Treat (MITT) analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | Baseline up to Month 36 (End of study) | MITT analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Month 13 up to Month 24 | Full immunization set (FIS) included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | Month 13 up to Month 36 (End of study) | FIS included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. | 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/NCT03060629/outcomes