Trial · NCT00345579
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
NCT00345579, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age. Trials, record NCT00345579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345579
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
- NCT number
- NCT00345579
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,432 participants, actual
- Lead sponsor
- GlaxoSmithKline
- 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, ActHIB, Pediarix/Infanrix Penta
- First posted
- 2006-06-28
- Last updated
- 2016-12-16
- Results first posted
- 2012-07-20
- Limitations and caveats
Solicited symptoms and unslocited AEs were not collected during this study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Primary | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Primary | Number of Subjects Reporting Rash | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. |
| Primary | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | |
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Primary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Primary | Number of Subjects With Rash | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae |
| Primary | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting Serious Adverse Events (SAEs) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting Rash | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Serious Adverse Events (SAEs) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Rash | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | MenHibrix Group | 109 | Subjects | ||
| Number of Subjects Reporting Serious Adverse Events (SAEs) | ActHIB Group | 33 | Subjects | ||
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | MenHibrix Group | 50 | Subjects | ||
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | ActHIB Group | 18 | Subjects | ||
| Number of Subjects Reporting Rash | MenHibrix Group | 243 | Subjects | ||
| Number of Subjects Reporting Rash | ActHIB Group | 81 | Subjects | ||
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | MenHibrix Group | 114 | Subjects | ||
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | ActHIB Group | 44 | Subjects | ||
| Number of Subjects With Serious Adverse Events (SAEs) | MenHibrix Group | 157 | Subjects | ||
| Number of Subjects With Serious Adverse Events (SAEs) | ActHIB Group | 48 | Subjects |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MenHibrix Group | 3,278 | |
| Overall Study | STARTED | ActHIB Group | 1,113 | |
| Overall Study | COMPLETED | MenHibrix Group | 3,114 | |
| Overall Study | COMPLETED | ActHIB Group | 1,048 | |
| Overall Study | NOT COMPLETED | MenHibrix Group | 164 | |
| Overall Study | NOT COMPLETED | ActHIB Group | 65 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Febrile convulsion | Nervous system disorders | MenHibrix Group | 5 | 3,278 | |
| serious | Febrile convulsion | Nervous system disorders | ActHIB Group | 1 | 1,113 | |
| serious | Fractured skull depressed | Injury, poisoning and procedural complications | MenHibrix Group | 0 | 3,278 | |
| serious | Fractured skull depressed | Injury, poisoning and procedural complications | ActHIB Group | 1 | 1,113 | |
| serious | Haematoma | Vascular disorders | MenHibrix Group | 1 | 3,278 | |
| serious | Haematoma | Vascular disorders | ActHIB Group | 0 | 1,113 | |
| serious | Haematuria | Renal and urinary disorders | MenHibrix Group | 1 | 3,278 | |
| serious | Haematuria | Renal and urinary disorders | ActHIB Group | 0 | 1,113 | |
| serious | Haemorrhage intracranial | Nervous system disorders | MenHibrix Group | 1 | 3,278 | |
| serious | Haemorrhage intracranial | Nervous system disorders | ActHIB Group | 0 | 1,113 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MenHibrix Group | ||
| Total, all-cause mortality | ActHIB Group | ||
| Total, other adverse events | MenHibrix Group | 0 | 0 |
| Total, other adverse events | ActHIB Group | 0 | 0 |
| Total, serious adverse events | MenHibrix Group | 157 | 3,278 |
| Total, serious adverse events | ActHIB Group | 48 | 1,113 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MenHibrix Group vs ActHIB Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00345579
GET https://conductscience.org/api/trials/v1/NCT00345579/events?page=2