Trial · NCT05168813
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With a First Occurrence of CDC-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1) | 1 day after Month 1 dose until Month 6 dose | FAS | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With a First Occurrence of COVE-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1 | 1 day after Month 0 dose until Month 6 dose | FAS | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1) | 1 day after Month 0 dose until Month 6 dose | FAS | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Groups | 14 days after Month 6 dose until end of follow up (up to 18 months) | Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With a First Occurrence of COVE-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Group | 14 days after Month 6 dose until end of follow up (up to 18 months) | Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Groups | 14 days after Month 6 dose until end of follow up (up to 18 months) | Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Solicited Adverse Events in the Safety Subset | Up to 7 days following Month 0 vaccination (all Study Groups) and up to 7 days following Month 1 vaccination (Study Groups 1 and 3) | Safety subset. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Solicited Adverse Events in the Safety Subset | Up to 7 days following Month 6 vaccination | Participants in the safety subset who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset | Up to 28 days following Month 0 vaccination (all Study Groups) and up to 28 days following Month 1 vaccination (Study Groups 1 and 3) | Safety subset. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset | Up to 28 days following Month 6 vaccination | Participants in the safety subset who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Serious Adverse Events (SAEs) | Up to Month 6 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Serious Adverse Events (SAEs) | Day of Month 6 vaccination up to Month 18 | Participants who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected (FM6 cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Adverse Events of Special Interest (AESIs) | Up to Month 6 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Adverse Events of Special Interest (AESIs) | Day of Month 6 vaccination up to Month 18 | Participants who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected (FM6 cohort). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With First CDC-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Status | 1 day after Month 0 dose until Month 6 dose | FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With First COVE-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Statu | 1 day after Month 0 dose until Month 6 dose | FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With First COVE-based Severe COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HI | 1 day after Month 0 dose until Month 6 dose | FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Hybrid Immunity Between Month 6 Monovalent and Bivalent Boost Groups | 14 days after Month 6 dose until end of follow up (up to 18 months) | Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort) and have Month 6 hybrid immunity. Hybrid immunity is defined as any evidence of prior SARS-CoV-2 infection up to the Month 6 visit, defined by meeting any of the following criteria: 1) baseline overall SARS-CoV-2 status positive, 2) at least one NAAT result at or prior to Month 6 is positive, or 3) at least one anti-NP tests at or prior to Month 6 is positive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Vaccine Immunity Between Month 6 Monovalent and Bivalent Boost Group | 14 days after Month 6 dose until end of follow up (up to 18 months) | Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort) and have Month 6 vaccine immunity. Vaccine immunity is defined as absence of evidence of prior SARS-C | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody (NAb) Assay | Month 0, 4 weeks post final pre-Month 6 vaccination (peak timepoint) | Per-protocol serum immunogenicity set with antibody marker data available at Month 0 and peak timepoint. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts. The purpose is to summarize NAb responses by vaccine regimen (hybrid vs vaccine), as well as within people living with HIV (PWH) and people living without HIV (PWoH) respectively. | AU/ml | GEOMETRIC_MEAN |
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/NCT05168813/outcomes