Trial · NCT05168813
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
NCT05168813, Phase 2, Phase 3, Completed, COVID-19 Prevention Network; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern. Trials, record NCT05168813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05168813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
- NCT number
- NCT05168813
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 14,237 participants, actual
- Lead sponsor
- COVID-19 Prevention Network
- Conditions
- SARS-CoV-2 Infection, HIV Infections, COVID-19
- Interventions
- Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose, Vaccine 2 Dose
- First posted
- 2021-12-23
- Last updated
- 2026-04-21
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. Because additional NAAT testing was performed at Month 1 for AG1 but not AG2-1, NAAT results at Month 1 were not considered. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication. |
| 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 | The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication. |
| 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 | The COVE-based severe COVID-19 endpoint is defined as the first occurrence of a confirmed case of COVE-based COVID-19, plus any of the following: 1. Clinical signs indicative of severe systemic illness, Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 less than 300 mm Hg, OR 2. Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure less than 90 mmHg, diastolic BP less than 60 mmHg or requiring vasopressors), OR 3. Significant acute renal, hepatic, or neurologic dysfunction, OR 4. Admission to an intensive care unit or death. The severe COVE criteria require adjudication. |
| 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) | The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication. |
| 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) | The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication. |
| 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) | Statistical analyses were not performed because there are fewer than 7 severe COVE-based severe COVID-19 starting 14 days after Month 6 dose until end of follow up in RM6 cohort. |
| 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) | All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea. |
| Primary | Part B: Number of Participants With Solicited Adverse Events in the Safety Subset | Up to 7 days following Month 6 vaccination | All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea. |
| 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) | All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. |
| Primary | Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset | Up to 28 days following Month 6 vaccination | All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group912
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Part A (Open-label): Study Group 1, Analysis Group 1 (AG1) | 76 | Participants | ||
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) | Part A (Open-label): Study Group 2, Analysis Group 2-1 (AG2-1) | 151 | Participants | ||
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 | Part A (Open-label): Study Group 1, Analysis Group 1 (AG1) | 30 | Participants | ||
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 | Part A (Open-label): Study Group 2, Analysis Group 2-1 (AG2-1) | 40 | Participants | ||
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) | Part A (Open-label): Study Group 1, Analysis Group 1 (AG1) | 5 | Participants | ||
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) | Part A (Open-label): Study Group 2, Analysis Group 2-1 (AG2-1) | 4 | Participants | ||
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 | Part B (Blinded): mRNA-1273 at Month 6 | 151 | Participants | ||
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 | Part B (Blinded): mRNA-1273.222 at Month 6 | 142 | Participants | ||
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 | Part B (Blinded): mRNA-1273 at Month 6 | 8 | Participants | ||
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 | Part B (Blinded): mRNA-1273.222 at Month 6 | 7 | Participants |
1 to 10 of 912Source ClinicalTrials.gov
See all 912 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Open-label) | STARTED | Part A (Open-label): Study Group 1 | 3,740 | |
| Part A (Open-label) | STARTED | Part A (Open Label): Study Group 2 | 7,941 | |
| Part A (Open-label) | STARTED | Part A (Open-label): Study Group 3 | 648 | |
| Part A (Open-label) | STARTED | Part A (Open-label): Study Group 4 | 1,672 | |
| Part A (Open-label) | STARTED | Part B (Blinded): mRNA-1273 at Month 6 | 0 | |
| Part A (Open-label) | STARTED | Part B (Blinded): mRNA-1273.222 at Month 6 | 0 | |
| Part A (Open-label) | Full Analysis Set (FAS) | Part A (Open-label): Study Group 1 | 3,740 | |
| Part A (Open-label) | Full Analysis Set (FAS) | Part A (Open Label): Study Group 2 | 7,941 | |
| Part A (Open-label) | Full Analysis Set (FAS) | Part A (Open-label): Study Group 3 | 648 | |
| Part A (Open-label) | Full Analysis Set (FAS) | Part A (Open-label): Study Group 4 | 1,672 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events1,920
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 1 | 0 | 558 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A (Open Label): Study Group 2 | 0 | 692 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 3 | 0 | 99 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 4 | 0 | 142 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B (Blinded): mRNA-1273 at Month 6 | 1 | 1,323 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part B (Blinded): mRNA-1273.222 at Month 6 | 0 | 89 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 1 | 1 | 558 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part A (Open Label): Study Group 2 | 0 | 692 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 3 | 0 | 99 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part A (Open-label): Study Group 4 | 0 | 142 | 0 |
1 to 10 of 1,920Source ClinicalTrials.gov
See all 1,920 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A (Open-label): Study Group 1 | 24 | 3,740 |
| Total, all-cause mortality | Part A (Open Label): Study Group 2 | 31 | 7,941 |
| Total, all-cause mortality | Part A (Open-label): Study Group 3 | 1 | 648 |
| Total, all-cause mortality | Part A (Open-label): Study Group 4 | 9 | 1,672 |
| Total, all-cause mortality | Part B (Blinded): mRNA-1273 at Month 6 | 63 | 11,243 |
| Total, all-cause mortality | Part B (Blinded): mRNA-1273.222 at Month 6 | 19 | 2,012 |
| Total, other adverse events | Part A (Open-label): Study Group 1 | 308 | 558 |
| Total, other adverse events | Part A (Open Label): Study Group 2 | 270 | 692 |
| Total, other adverse events | Part A (Open-label): Study Group 3 | 47 | 99 |
| Total, other adverse events | Part A (Open-label): Study Group 4 | 62 | 142 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39902315 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1AI068614 | HIV Vaccines Clinical Trials Network Leadership and Operations Center | COREY, LAWRENCE; BAROUCH, DAN H.; GRAY, GLENDA E; TOMARAS, GEORGIA DORIS | FRED HUTCHINSON CANCER CENTER | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2011 to 2025 |
Source NIH RePORTER
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part B (Blinded): mRNA-1273 at Month 6 vs Part B (Blinded): mRNA-1273.222 at Month 6: Part B: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
Part B (Blinded): mRNA-1273 at Month 6 vs Part B (Blinded): mRNA-1273.222 at Month 6: 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 | Trial comparisons |
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) vs Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1): 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 | Trial comparisons |
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) vs Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1): 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 | Trial comparisons |
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) vs Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1): 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 | Trial comparisons |
Part B (Blinded): mRNA-1273 at Month 6 vs Part B (Blinded): mRNA-1273.222 at Month 6: 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 | Trial comparisons |
Part A (Open-label): Study Group 1, Analysis Group 1 (AG1) vs Part A (Open-label): Study Group 2, Analysis Group 2-1 (AG2-1): 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 | Trial comparisons |
Part B (Blinded): Monovalent, Month 6 Vaccine Immunity vs Part B (Blinded): Bivalent, Month 6 Vaccine Immunity: 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 | Trial comparisons |
| Part B (Blinded): mRNA-1273 at Month 6 vs Part B (Blinded): mRNA-1273.222 at Month 6: Part B: Number of Participants With Adverse Events of Special Interest (AESIs) | Trial comparisons |
Part B (Blinded): Monovalent, Month 6 Hybrid Immunity vs Part B (Blinded): Bivalent, Month 6 Hybrid Immunity: 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 | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT05168813/registered?page=2