Trial · NCT00514904
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
NCT00514904, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects. Trials, record NCT00514904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
- NCT number
- NCT00514904
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,504 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Meningococcal, Meningococcal Vaccines
- Interventions
- Nimenrix, Mencevax
- First posted
- 2007-08-10
- Last updated
- 2020-10-27
- Other registries' IDs
- eudract:2012-000283-23
- Results first posted
- 2017-10-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | One month after vaccination (Post-vaccination, study Month 1) | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8). |
| Primary | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | During the 4-day (Days 0-3) post-vaccination period | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Pre vaccination (Month 0) and post vaccination (Month 1) | Antibody titers were expressed as geometric mean titers (GMTs). |
| Secondary | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively. |
| Secondary | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | Antibody concentrations were expressed as geometric mean concentrations (GMCs) |
| Secondary | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination, (Month 1) | The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. |
| Secondary | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. |
| Secondary | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. |
| Secondary | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | One month after vaccination (Post-vaccination, study Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | During the 4-day (Days 0-3) post-vaccination period | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Pre vaccination (Month 0) and post vaccination (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination, (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Nimenrix Group | rSBA-MenA | 529 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Mencevax ACWY Group | rSBA-MenA | 124 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Nimenrix Group | rSBA-MenC | 664 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Mencevax ACWY Group | rSBA-MenC | 210 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Nimenrix Group | rSBA-MenW-135 | 673 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Mencevax ACWY Group | rSBA-MenW-135 | 195 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Nimenrix Group | rSBA-MenY | 670 | Participants | |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Mencevax ACWY Group | rSBA-MenY | 165 | Participants | |
| Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Nimenrix Group | 10 | Participants | ||
| Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Mencevax ACWY Group | 1 | Participants |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nimenrix Group | 1,125 | |
| Overall Study | STARTED | Mencevax ACWY Group | 376 | |
| Overall Study | COMPLETED | Nimenrix Group | 1,101 | |
| Overall Study | COMPLETED | Mencevax ACWY Group | 371 | |
| Overall Study | NOT COMPLETED | Nimenrix Group | 24 | |
| Overall Study | NOT COMPLETED | Mencevax ACWY Group | 5 |
Source ClinicalTrials.gov
Adverse events66
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 | Pain (< 6 years of age) | General disorders | Nimenrix Group | 104 | 575 | |
| other | Pain (< 6 years of age) | General disorders | Mencevax ACWY Group | 39 | 188 | |
| other | Redness (< 6 years of age) | General disorders | Nimenrix Group | 82 | 575 | |
| other | Redness (< 6 years of age) | General disorders | Mencevax ACWY Group | 31 | 188 | |
| other | Swelling (< 6 years of age) | General disorders | Nimenrix Group | 31 | 575 | |
| other | Swelling (< 6 years of age) | General disorders | Mencevax ACWY Group | 15 | 188 | |
| other | Pain (≥ 6 years of age) | General disorders | Nimenrix Group | 105 | 575 | |
| other | Pain (≥ 6 years of age) | General disorders | Mencevax ACWY Group | 50 | 188 | |
| other | Redness (≥ 6 years of age) | General disorders | Nimenrix Group | 107 | 542 | |
| other | Redness (≥ 6 years of age) | General disorders | Mencevax ACWY Group | 36 | 186 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nimenrix Group | 0 | 1,125 |
| Total, all-cause mortality | Mencevax ACWY Group | 0 | 376 |
| Total, other adverse events | Nimenrix Group | 416 | 1,125 |
| Total, other adverse events | Mencevax ACWY Group | 155 | 376 |
| Total, serious adverse events | Nimenrix Group | 15 | 1,125 |
| Total, serious adverse events | Mencevax ACWY Group | 7 | 376 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21278617 | BACKGROUND |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nimenrix Group vs Mencevax ACWY Group: Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Trial comparisons |
| Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Trial comparisons |
| Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting Any Unsolicited Symptoms | Trial comparisons |
| Nimenrix Group vs Mencevax ACWY Group: deaths from any cause | Trial comparisons |
| Nimenrix Group vs Mencevax ACWY Group: serious adverse events | 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/NCT00514904
GET https://conductscience.org/api/trials/v1/NCT00514904/results?page=2