Trial · NCT00453986
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
NCT00453986, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults. Trials, record NCT00453986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
- NCT number
- NCT00453986
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,352 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Meningococcal
- Interventions
- Meningococcal vaccine GSK134612, Mencevax™ACWY, Fluarix™
- First posted
- 2007-03-29
- Last updated
- 2018-09-25
- Results first posted
- 2012-05-22
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | One month after vaccination (at Month 1) | Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Primary | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | One month after vaccination (at Month 1) | Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Primary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | One month after vaccination (at Month 1) | Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort). |
| Primary | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Primary | Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer \>1:40, or a pre-vaccination titer \>1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain. Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Primary | Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Primary | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1) | Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | Prior to vaccination (at Month 0). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort). |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | One month after vaccination (at Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | One month after vaccination (at Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | One month after vaccination (at Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1). | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Fold increase in serum HI GMTs | MEAN |
| PRIMARY | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1) | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | Prior to and one month after vaccination (at Month 0 and Month 1). | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | Prior to vaccination (at Month 0). | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group519
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix A Group | rSBA-MenA | 3913.1 | 95% Confidence Interval 3468.9 to 4414.1 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix B Group | rSBA-MenA | 3503.5 | 95% Confidence Interval 3083.0 to 3981.4 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix C Group | rSBA-MenA | 3470.8 | 95% Confidence Interval 3051.7 to 3947.3 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix A Group | rSBA-MenC | 9467.0 | 95% Confidence Interval 7980.2 to 11230.7 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix B Group | rSBA-MenC | 8118.7 | 95% Confidence Interval 6818.9 to 9666.3 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix C Group | rSBA-MenC | 9051.0 | 95% Confidence Interval 7538.6 to 10866.8 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix A Group | rSBA-MenW-135 | 5263.2 | 95% Confidence Interval 4527.0 to 6119.1 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix B Group | rSBA-MenW-135 | 4890.6 | 95% Confidence Interval 4145.5 to 5769.6 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix C Group | rSBA-MenW-135 | 5260.1 | 95% Confidence Interval 4536.8 to 6098.7 | Titers |
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | Nimenrix A Group | rSBA-MenY | 7872.7 | 95% Confidence Interval 6849.0 to 9049.3 | Titers |
1 to 10 of 519Source ClinicalTrials.gov
See all 519 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nimenrix A Group | 311 | |
| Overall Study | STARTED | Nimenrix B Group | 311 | |
| Overall Study | STARTED | Nimenrix C Group | 313 | |
| Overall Study | STARTED | Mencevax ACWY Group | 312 | |
| Overall Study | STARTED | Nimenrix+Fluarix Group | 105 | |
| Overall Study | COMPLETED | Nimenrix A Group | 305 | |
| Overall Study | COMPLETED | Nimenrix B Group | 306 | |
| Overall Study | COMPLETED | Nimenrix C Group | 307 | |
| Overall Study | COMPLETED | Mencevax ACWY Group | 310 | |
| Overall Study | COMPLETED | Nimenrix+Fluarix Group | 105 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events45
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 | General disorders | Nimenrix Group | 180 | 935 | |
| other | Pain | General disorders | Mencevax ACWY Group | 42 | 312 | |
| other | Pain | General disorders | Nimenrix+Fluarix Group | 37 | 105 | |
| other | Redness | General disorders | Nimenrix Group | 82 | 935 | |
| other | Redness | General disorders | Mencevax ACWY Group | 14 | 312 | |
| other | Redness | General disorders | Nimenrix+Fluarix Group | 11 | 105 | |
| other | Swelling | General disorders | Nimenrix Group | 73 | 935 | |
| other | Swelling | General disorders | Mencevax ACWY Group | 6 | 312 | |
| other | Swelling | General disorders | Nimenrix+Fluarix Group | 10 | 105 | |
| other | Fatigue | General disorders | Nimenrix Group | 114 | 935 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nimenrix Group | 0 | 935 |
| Total, all-cause mortality | Mencevax ACWY Group | 0 | 312 |
| Total, all-cause mortality | Nimenrix+Fluarix Group | 0 | 105 |
| Total, other adverse events | Nimenrix Group | 330 | 935 |
| Total, other adverse events | Mencevax ACWY Group | 89 | 312 |
| Total, other adverse events | Nimenrix+Fluarix Group | 49 | 105 |
| Total, serious adverse events | Nimenrix Group | 7 | 935 |
| Total, serious adverse events | Mencevax ACWY Group | 1 | 312 |
| Total, serious adverse events | Nimenrix+Fluarix Group | 0 | 105 |
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 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 Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Trial comparisons |
Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Trial comparisons |
Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Trial comparisons |
Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Trial comparisons |
Nimenrix Group vs Mencevax ACWY Group: Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 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.
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