Trial · NCT03060629
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| 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) | Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| 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) | Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| 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) | Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| 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) | Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| 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) | Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| 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) | Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| 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) | Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| 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) | Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| 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) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| 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) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| 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) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| 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) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) | Up to Month 36 (up to end of the study) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Primary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Up to Month 36 (up to end of the study) | Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study. |
| 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) | Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment. |
| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Baseline up to Month 24 | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| 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) | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Month 13 up to Month 24 | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| 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) | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03060629/registered