Comparison · NCT00345683-sae
Menhibrix Group vs ActHIB Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Menhibrix Group vs ActHIB Group: serious adverse events. Trial comparisons, record NCT00345683-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00345683-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 | 0.0239 | 0.019 | 0.03 | wilson | |
| Risk in group 2 | 0.0178 | 0.0113 | 0.028 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0061 | -0.00519 | 0.015 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 0.805 | 2.24 | log | |
| Odds ratio, group 1 over group 2 | 1.35 | 0.802 | 2.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Menhibrix Group than on ActHIB Group | 164 | 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 | Menhibrix Group | Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 72 | 3,010 | EG000 |
| Group 2 | ActHIB Group | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 18 | 1,010 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Source ClinicalTrials.gov
Trial
- Title
- Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
- NCT number
- NCT00345683
- Phases
- PHASE3
- Conditions
- Haemophilus Influenzae Type b, Neisseria Meningitidis
- Interventions
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB, Prevnar, M-M-R II, Varivax
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00345683?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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