Herpes Simplex Virus Group vs Havrix Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0381 | 0.0329 | 0.0441 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.036 | 0.0305 | 0.0426 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00206 | -0.00631 | 0.0102 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.846 | 1.32 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.84 | 1.34 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Herpes Simplex Virus Group than on Havrix Group | 486 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Herpes Simplex Virus Group | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. | 171 | 4,488 | EG000 | ClinicalTrials.gov |
| Group 2 | Havrix Group | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. | 132 | 3,662 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Solicited local and general symptoms: during the 7-day (Day 0-6) follow-up period after vaccination. Unsolicited adverse events: during the 31 days following vaccination period. Serious adverse events: from Month 0 up to Month 20 | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | HerpeVac Trial for Young Women | ClinicalTrials.gov |
| NCT number | NCT00057330 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Herpes Simplex Infection | ClinicalTrials.gov |
| Interventions | HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine, Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2011-11-03 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00057330?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.