Comparison · NCT01162122-fd2fb590
aTIV (Pooled) vs Licensed TIV: Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine 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. aTIV (Pooled) vs Licensed TIV: Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups. Trial comparisons, record NCT01162122-fd2fb590. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01162122-fd2fb590
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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 | 0.0421 | 0.0325 | 0.0544 | wilson | |
| Risk in group 2 | 0.0375 | 0.0284 | 0.0493 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00461 | -0.0107 | 0.0199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.768 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.76 | 1.68 | log | |
| Number needed to treat, for one more participant with the outcome on aTIV (Pooled) than on Licensed TIV | 217 | 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 | aTIV (Pooled) | Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3). | 55 | 1,307 | OG000 |
| Group 2 | Licensed TIV | Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV). | 48 | 1,281 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
- Description
The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
- Time frame
- Day 1 through Day 366 post vaccination
- Population
- Analysis was done on the mFAS (effectiveness) population.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
- NCT number
- NCT01162122
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- MF59 adjuvanted trivalent subunit influenza vaccine (aTIV), Non-adjuvanted trivalent subunit influenza vaccine (TIV)
- Lead sponsor
- Novartis Vaccines
- Results first posted
- 2014-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01162122?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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