Trial · NCT00289783
Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
NCT00289783, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine. Trials, record NCT00289783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00289783
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
- NCT number
- NCT00289783
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,441 participants, actual
- Lead sponsor
- GlaxoSmithKline
- 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
- First posted
- 2006-02-10
- Last updated
- 2018-08-24
- Results first posted
- 2012-08-06
Source ClinicalTrials.gov
Registered outcomes72
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | One month after primary vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) 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. |
| Primary | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured 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. |
| Primary | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | Titers are expressen as Geometric Mean Titers (GMTs) 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. |
| Primary | hSBA-MenC Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | Titers are expressed as Geometric Mean Titers (GMTs) 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. |
| Primary | hSBA-MenY Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | Titers are expressed as Geometric Mean Titers (GMTs) 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. |
| Primary | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | One month after primary vaccination | 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. |
| Primary | Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | 42 days after the fourth dose | 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. |
| Primary | Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 | 42 days after the fourth dose | 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. |
| Primary | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) | 42 days after the fourth dose | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine |
| Primary | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | 42 days after the fourth dose | 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. |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 registered outcomesOutcomes72
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | One month after primary vaccination | The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose. | Titers | GEOMETRIC_MEAN |
| PRIMARY | hSBA-MenC Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | 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. | Titers | GEOMETRIC_MEAN |
| PRIMARY | hSBA-MenY Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | 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. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | One month after primary vaccination | The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | 42 days after the fourth dose | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 | 42 days after the fourth dose | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) | 42 days after the fourth dose | The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | 42 days after the fourth dose | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 outcomesResults by group426
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | Menhibrix A Group | 10.170 | 95% Confidence Interval 8.855 to 11.681 | microgram per milliliter (µg/mL) | |
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | Menhibrix B Group | 11.424 | 95% Confidence Interval 9.710 to 13.441 | microgram per milliliter (µg/mL) | |
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | Menhibrix C Group | 11.438 | 95% Confidence Interval 9.503 to 13.768 | microgram per milliliter (µg/mL) | |
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | Menhibrix Group | 11.021 | 95% Confidence Interval 10.027 to 12.114 | microgram per milliliter (µg/mL) | |
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | ActHIB Group | 6.463 | 95% Confidence Interval 5.288 to 7.900 | microgram per milliliter (µg/mL) | |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | Menhibrix A Group | 910.0 | 95% Confidence Interval 754.6 to 1097.3 | Titers | |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | Menhibrix B Group | 1118.0 | 95% Confidence Interval 931.1 to 1342.5 | Titers | |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | Menhibrix C Group | 885.7 | 95% Confidence Interval 712.4 to 1101.2 | Titers | |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | Menhibrix Group | 967.6 | 95% Confidence Interval 864.0 to 1083.5 | Titers | |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | ActHIB Group | 2.5 | 95% Confidence Interval 2.2 to 2.9 | Titers |
1 to 10 of 426Source ClinicalTrials.gov
See all 426 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Phase | STARTED | Menhibrix Group | 3,136 | |
| Primary Phase | STARTED | ActHIB Group | 1,044 | |
| Primary Phase | COMPLETED | Menhibrix Group | 2,888 | |
| Primary Phase | COMPLETED | ActHIB Group | 961 | |
| Primary Phase | NOT COMPLETED | Menhibrix Group | 248 | |
| Primary Phase | NOT COMPLETED | ActHIB Group | 83 | |
| Fourth Dose Phase | STARTED | Menhibrix Group | 2,769 | |
| Fourth Dose Phase | STARTED | ActHIB Group | 923 | |
| Fourth Dose Phase | COMPLETED | Menhibrix Group | 2,682 | |
| Fourth Dose Phase | COMPLETED | ActHIB Group | 899 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events316
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 |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Menhibrix Group | 524 | 3,136 | |
| other | Upper respiratory tract infection | Infections and infestations | ActHIB Group | 173 | 1,044 | |
| other | Otitis media | Infections and infestations | Menhibrix Group | 335 | 3,136 | |
| other | Otitis media | Infections and infestations | ActHIB Group | 104 | 1,044 | |
| other | Vomiting | Gastrointestinal disorders | Menhibrix Group | 197 | 3,136 | |
| other | Vomiting | Gastrointestinal disorders | ActHIB Group | 65 | 1,044 | |
| other | Pyrexia | General disorders | Menhibrix Group | 176 | 3,136 | |
| other | Pyrexia | General disorders | ActHIB Group | 73 | 1,044 | |
| other | Diarrhoea | Gastrointestinal disorders | Menhibrix Group | 185 | 3,136 | |
| other | Diarrhoea | Gastrointestinal disorders | ActHIB Group | 57 | 1,044 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 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 | 3,034 | 3,136 |
| Total, other adverse events | ActHIB Group | 998 | 1,044 |
| Total, serious adverse events | Menhibrix Group | 126 | 3,136 |
| Total, serious adverse events | ActHIB Group | 50 | 1,044 |
Source ClinicalTrials.gov
Papers4
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 comparisons27
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s) | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL) | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects With Anti-varicella Titer Equal to or Above 1:40 | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Serious Adverse Events (SAEs) | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | Trial comparisons |
| Menhibrix Group vs ActHIB Group: Number of Subjects Reporting Serious Adverse Events (SAEs) | Trial comparisons |
1 to 10 of 27
See all 27 trial comparisonsTests0
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/NCT00289783
GET https://conductscience.org/api/trials/v1/NCT00289783/registered?page=2