Comparison · NCT05168813-dd295266
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
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): 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, record NCT05168813-dd295266. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05168813-dd295266
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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 | 0.0808 | 0.0689 | 0.0946 | wilson | |
| Risk in group 2 | 0.0699 | 0.0589 | 0.0828 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0109 | -0.00665 | 0.0285 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.916 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.909 | 1.5 | log | |
| Number needed to treat, for one more participant with the outcome on Part B (Blinded): Monovalent, Month 6 Hybrid Immunity than on Part B (Blinded): Bivalent, Month 6 Hybrid Immunity | 91.7 | 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): Monovalent, Month 6 Hybrid Immunity | Participants who received mRNA1273 and have hybrid immunity at Month 6. 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. | 140 | 1,732 | OG000 |
| Group 2 | Part B (Blinded): Bivalent, Month 6 Hybrid Immunity | Participants who received mRNA1273.222 and have hybrid immunity at Month 6. 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. | 123 | 1,759 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
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
- Description
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on these 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 date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not 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) 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.
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.
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