Comparison · NCT00860067-da4d2d54
Q/LAIV (MEDI3250) vs All FluMist: Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
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. Q/LAIV (MEDI3250) vs All FluMist: Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination. Trial comparisons, record NCT00860067-da4d2d54. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00860067-da4d2d54
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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 | 0.00167 | 0.000458 | 0.00607 | wilson | |
| Risk in group 2 | 0.00334 | 0.000918 | 0.0121 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00168 | -0.0105 | 0.00335 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.499 | 0.0705 | 3.53 | log | |
| Odds ratio, group 1 over group 2 | 0.498 | 0.07 | 3.55 | log | |
| Number needed to treat, for one fewer participant with the outcome on Q/LAIV (MEDI3250) than on All FluMist | 597 | 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 | Q/LAIV (MEDI3250) | Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], B/Victoria \[B/Malaysia/2506/2004\], and B/Yamagata \[B/Florida/4/2006\]). | 2 | 1,198 | OG000 |
| Group 2 | All FluMist | Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined. | 2 | 598 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
- Description
Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
- Time frame
- Days 0-28 post vaccination
- Population
- The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
- NCT number
- NCT00860067
- Phases
- PHASE2, PHASE3
- Conditions
- Healthy or Stable Underlying Chronic Medical Condition
- Interventions
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2011-08-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00860067?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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