Comparison · NCT05168813-f3162916
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 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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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 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. Trial comparisons, record NCT05168813-f3162916. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05168813-f3162916
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00405 | 0.00205 | 0.00797 | wilson | |
| Risk in group 2 | 0.00348 | 0.00169 | 0.00716 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000569 | -0.00362 | 0.00488 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.423 | 3.2 | log | |
| Odds ratio, group 1 over group 2 | 1.16 | 0.421 | 3.22 | log | |
| Number needed to treat, for one more participant with the outcome on Part B (Blinded): mRNA-1273 at Month 6 than on Part B (Blinded): mRNA-1273.222 at Month 6 | 1,760 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Part B (Blinded): mRNA-1273 at Month 6 | Received monovalent booster at Month 6 | 8 | 1,976 | OG000 |
| Group 2 | Part B (Blinded): mRNA-1273.222 at Month 6 | Received bivalent booster at Month 6 | 7 | 2,012 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
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
- Description
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.
- Time frame
- 14 days after Month 6 dose until end of follow up (up to 18 months)
- Population
- Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
- NCT number
- NCT05168813
- Phases
- PHASE2, PHASE3
- Conditions
- SARS-CoV-2 Infection, HIV Infections, COVID-19
- Interventions
- Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose, Vaccine 2 Dose
- Lead sponsor
- COVID-19 Prevention Network
- Results first posted
- 2025-11-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05168813?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05168813-f3162916