Synflorix Group vs Control Group: deaths from any cause
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 | 0.00161 | 0.00103 | 0.00251 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0022 | 0.0015 | 0.00323 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000593 | -0.00177 | 0.000549 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.731 | 0.405 | 1.32 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.73 | 0.404 | 1.32 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on Synflorix Group than on Control Group | 1,690 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Synflorix Group | Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose). | 19 | 11,798 | EG000 | ClinicalTrials.gov |
| Group 2 | Control Group | Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. | 26 | 11,799 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine | ClinicalTrials.gov |
| NCT number | NCT00466947 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Infections, Streptococcal | ClinicalTrials.gov |
| Interventions | Pneumococcal conjugate vaccine GSK1024850A, Havrix, Engerix-B, Infanrix hexa, GSK Biologicals' DTPa-IPV/Hib vaccine | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2013-09-04 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00466947?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.