Comparison · NCT01352793-sae
Group 1: rLP2086 vs Group 2: HAV/Saline/HAV: 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. Group 1: rLP2086 vs Group 2: HAV/Saline/HAV: serious adverse events. Trial comparisons, record NCT01352793-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01352793-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 | 0.0155 | 0.0121 | 0.02 | wilson | |
| Risk in group 2 | 0.0252 | 0.019 | 0.0332 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00961 | -0.0184 | -0.00204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.618 | 0.424 | 0.901 | log | |
| Odds ratio, group 1 over group 2 | 0.612 | 0.416 | 0.899 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group 1: rLP2086 than on Group 2: HAV/Saline/HAV | 104 | 54.4 | 491 | from the risk difference interval |
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 | Group 1: rLP2086 | Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule | 59 | 3,796 | EG000 |
| Group 2 | Group 2: HAV/Saline/HAV | Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month | 48 | 1,908 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
Source ClinicalTrials.gov
Trial
- Title
- A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
- NCT number
- NCT01352793
- Phases
- PHASE3
- Conditions
- Meningitis, Meningococcal
- Interventions
- rLP2086 vaccine, control
- Lead sponsor
- Pfizer
- Results first posted
- 2015-03-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01352793?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.govNone 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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