gD2-AS04 Group vs Pooled Group: Number of Subjects With Serious Adverse Events (SAEs)
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 | 0.0302 | 0.0247 | 0.037 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0336 | 0.0277 | 0.0407 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00335 | -0.0124 | 0.00564 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.9 | 0.68 | 1.19 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.897 | 0.672 | 1.2 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on gD2-AS04 Group than on Pooled Group | 299 | 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 | gD2-AS04 Group | Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. | 90 | 2,977 | OG000 | ClinicalTrials.gov |
| Group 2 | Pooled Group | Pooled group of subjects 10-17 years of age from Havrix and Saline groups. | 100 | 2,978 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Subjects With Serious Adverse Events (SAEs) | ClinicalTrials.gov |
| Description | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled. | ClinicalTrials.gov |
| Time frame | Up to month 18 (during active phase and ESFU period) | ClinicalTrials.gov |
| Population | The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. For the purpose of this analysis, the subjects from Havrix Group and Saline group were pooled into one group: Pooled Group. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old | ClinicalTrials.gov |
| NCT number | NCT00224484 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Herpes Simplex | ClinicalTrials.gov |
| Interventions | GSK208141, Havrix (investigational formulation), Placebo | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2017-04-10 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00224484?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.