Comparison · NCT01091246-sae
Q/LAIV (MEDI3250) vs All FluMist Group: serious adverse events
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 Group: serious adverse events. Trial comparisons, record NCT01091246-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01091246-sae
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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 | 0.00434 | 0.00199 | 0.00944 | wilson | |
| Risk in group 2 | 0.00542 | 0.00232 | 0.0126 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00108 | -0.00865 | 0.00489 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.801 | 0.245 | 2.62 | log | |
| Odds ratio, group 1 over group 2 | 0.801 | 0.244 | 2.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Q/LAIV (MEDI3250) than on All FluMist Group | 930 | 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 live attenuated 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 resassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], B/Victoria \[B/Malaysia/2506/2004\], and B/Yamagata \[B/Florida/4/2006\]). | 6 | 1,382 | EG000 |
| Group 2 | All FluMist Group | All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined | 5 | 923 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from Day 0 through 28 after Doses 1 and 2. Serious adverse events were collected between Days 0-180 after the last dose administered.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
- NCT number
- NCT01091246
- Phases
- PHASE3
- Conditions
- Healthy or Stable Chronic Illness
- Interventions
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2011-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01091246?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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