Comparison · NCT00617851-sae
Influenza Virus Vaccine (Pooled) vs Comparator Influenza Vaccine: 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. Influenza Virus Vaccine (Pooled) vs Comparator Influenza Vaccine: serious adverse events. Trial comparisons, record NCT00617851-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00617851-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 | 0.0091 | 0.00509 | 0.0162 | wilson | |
| Risk in group 2 | 0.0198 | 0.00773 | 0.0498 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0107 | -0.041 | 0.00331 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.459 | 0.148 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.455 | 0.143 | 1.44 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Influenza Virus Vaccine (Pooled) than on Comparator Influenza Vaccine | 93.4 | 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 | Influenza Virus Vaccine (Pooled) | One injection of the investigational influenza virus vaccine (all lots pooled) | 11 | 1,209 | EG000 |
| Group 2 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine | 4 | 202 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events were collected for 6 months after vaccination. All adverse events were collected for 21 days after vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
- NCT number
- NCT00617851
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine, Lot C of Influenza virus vaccine, Comparator influenza virus vaccine, All 3 consecutive lots of influenza virus vaccine pooled
- Lead sponsor
- Novartis Vaccines
- Results first posted
- 2010-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00617851?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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