Trial · NCT00345683
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
NCT00345683, 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 12 to 15 Months of Age. Trials, record NCT00345683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345683
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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 12 to 15 Months of Age.
- NCT number
- NCT00345683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,021 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), PedvaxHIB, Prevnar, M-M-R II, Varivax
- First posted
- 2006-06-28
- Last updated
- 2016-11-29
- Results first posted
- 2012-07-20
- Limitations and caveats
- 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 fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 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 fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Primary | Number of Subjects Reporting Rash | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae |
| Primary | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | |
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | 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) | 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 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) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Primary | Number of Subjects With Rash | 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) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae |
| Primary | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | 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
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 fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting Rash | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Serious Adverse Events (SAEs) | 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) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 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) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Rash | 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) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | 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) | The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose. | 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 | 12 | Subjects | ||
| Number of Subjects Reporting Serious Adverse Events (SAEs) | ActHIB Group | 1 | Subjects | ||
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | Menhibrix Group | 12 | Subjects | ||
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | ActHIB Group | 6 | Subjects | ||
| Number of Subjects Reporting Rash | Menhibrix Group | 123 | Subjects | ||
| Number of Subjects Reporting Rash | ActHIB Group | 41 | Subjects | ||
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | Menhibrix Group | 29 | Subjects | ||
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | ActHIB Group | 16 | Subjects | ||
| Number of Subjects With Serious Adverse Events (SAEs) | Menhibrix Group | 72 | Subjects | ||
| Number of Subjects With Serious Adverse Events (SAEs) | ActHIB Group | 18 | 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 | 3,010 | |
| Overall Study | STARTED | ActHIB Group | 1,010 | |
| Overall Study | COMPLETED | Menhibrix Group | 2,985 | |
| Overall Study | COMPLETED | ActHIB Group | 1,001 | |
| Overall Study | NOT COMPLETED | Menhibrix Group | 25 | |
| Overall Study | NOT COMPLETED | ActHIB Group | 9 |
Source ClinicalTrials.gov
Adverse events78
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 | Gastroenteritis | Infections and infestations | Menhibrix Group | 28 | 3,010 | |
| serious | Gastroenteritis | Infections and infestations | ActHIB Group | 7 | 1,010 | |
| serious | Dehydration | Metabolism and nutrition disorders | Menhibrix Group | 6 | 3,010 | |
| serious | Dehydration | Metabolism and nutrition disorders | ActHIB Group | 0 | 1,010 | |
| serious | Bronchiolitis | Infections and infestations | Menhibrix Group | 8 | 3,010 | |
| serious | Bronchiolitis | Infections and infestations | ActHIB Group | 3 | 1,010 | |
| serious | Staphylococcal infection | Infections and infestations | Menhibrix Group | 2 | 3,010 | |
| serious | Staphylococcal infection | Infections and infestations | ActHIB Group | 0 | 1,010 | |
| serious | Abscess | Infections and infestations | Menhibrix Group | 1 | 3,010 | |
| serious | Abscess | Infections and infestations | ActHIB Group | 0 | 1,010 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 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 | 3,010 |
| Total, other adverse events | ActHIB Group | 0 | 1,010 |
| Total, serious adverse events | Menhibrix Group | 72 | 3,010 |
| Total, serious adverse events | ActHIB Group | 18 | 1,010 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22327493 | DERIVED |
Source PubMed
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/NCT00345683
GET https://conductscience.org/api/trials/v1/NCT00345683/events?page=2