Comparison · NCT00289783-89d9e61e
Menhibrix Group vs ActHIB Group: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
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. Menhibrix Group vs ActHIB Group: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL). Trial comparisons, record NCT00289783-89d9e61e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00289783-89d9e61e
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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 | 0.666 | 0.614 | 0.714 | wilson | |
| Risk in group 2 | 0.464 | 0.375 | 0.556 | wilson | |
| Risk difference, group 1 minus group 2 | 0.201 | 0.0959 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 1.16 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 2.3 | 1.49 | 3.55 | log | |
| Number needed to treat, for one more participant with the outcome on Menhibrix Group than on ActHIB Group | 4.97 | 3.3 | 10.4 | 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 | Menhibrix Group | Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | 227 | 341 | OG000 |
| Group 2 | ActHIB Group | Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | 52 | 112 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
- Description
- This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
- Time frame
- Prior to the fourth dose vaccination
- Population
The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
- NCT number
- NCT00289783
- Phases
- PHASE3
- Conditions
- Haemophilus Influenzae Type b, Neisseria Meningitidis
- Interventions
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, ActHIB, PedvaxHIB, Pediarix, Prevnar, M-M-R II, Varivax
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-08-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00289783?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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