Trial · NCT00450437
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
NCT00450437, Phase 3, Completed, Novartis Vaccines; results first posted 2010-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults. Trials, record NCT00450437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450437
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
- NCT number
- NCT00450437
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,539 participants, actual
- Lead sponsor
- Novartis Vaccines
- Conditions
- Meningococcal Infections, Meningococcal Meningitis
- Interventions
- MenACWY CRM, Meningococcal ACWY Conjugate vaccine
- First posted
- 2007-03-22
- Last updated
- 2015-01-28
- Results first posted
- 2010-09-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | 28 days after vaccination | The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age) |
| Primary | Percentage of Seroresponders, Ages 11 to 18 Years | 28 days after vaccination | Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Primary | Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | 6 days after vaccination | Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity |
| Primary | Percentage of Seroresponders, Ages 19 to 55 Years | 28 days after vaccination | Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Secondary | Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years | 28 days after vaccination | The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Secondary | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | 28 days after vaccination | Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Secondary | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | 28 days after vaccination | Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). |
| Secondary | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Days 1 to 7 | Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years 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 | Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | 28 days after vaccination | The analysis was performed on the Per Protocol (PP) Population | Titers | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Seroresponders, Ages 11 to 18 Years | 28 days after vaccination | The analysis set was the per protocol (PP) population. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | 6 days after vaccination | The analysis was performed on the safety set. | Participants | NUMBER |
| SECONDARY | Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years | 28 days after vaccination | The Analysis set was the per protocol (PP) population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | 28 days after vaccination | The analyses set was performed on the per protocol (PP) population. | Percentage of participants | NUMBER |
| SECONDARY | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | 28 days after vaccination | The analysis set was the per protocol (PP) population. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Days 1 to 7 | The analysis was performed on the safety set. | Participants | NUMBER |
| PRIMARY | Percentage of Seroresponders, Ages 19 to 55 Years | 28 days after vaccination | The analysis set was the per protocol (PP) population. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 1 | Serogroup A | 29 | 95% Confidence Interval 23 to 38 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 2 | Serogroup A | 33 | 95% Confidence Interval 25 to 42 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 3 | Serogroup A | 31 | 95% Confidence Interval 24 to 40 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 1 | Serogroup C (N=499, 493, 491) | 77 | 95% Confidence Interval 58 to 102 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 2 | Serogroup C (N=499, 493, 491) | 58 | 95% Confidence Interval 43 to 77 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 3 | Serogroup C (N=499, 493, 491) | 64 | 95% Confidence Interval 48 to 86 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 1 | Serogroup W (N=340, 341, 343) | 87 | 95% Confidence Interval 70 to 108 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 2 | Serogroup W (N=340, 341, 343) | 111 | 95% Confidence Interval 89 to 138 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 3 | Serogroup W (N=340, 341, 343) | 82 | 95% Confidence Interval 66 to 102 | Titers |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | Novartis MenACWY Lot 1 | Serogroup Y (N=345, 345, 346) | 48 | 95% Confidence Interval 37 to 62 | Titers |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Novartis MenACWY Vaccine (11 to 18 Years) | 1,640 | |
| Overall Study | STARTED | Licensed Meningococcal Vaccine (11 to 18 Years) | 540 | |
| Overall Study | STARTED | Novartis MenACWY Vaccine (19 to 55 Years) | 1,023 | |
| Overall Study | STARTED | Licensed Meningococcal Vaccine (19 to 55 Years) | 336 | |
| Overall Study | COMPLETED | Novartis MenACWY Vaccine (11 to 18 Years) | 1,594 | |
| Overall Study | COMPLETED | Licensed Meningococcal Vaccine (11 to 18 Years) | 524 | |
| Overall Study | COMPLETED | Novartis MenACWY Vaccine (19 to 55 Years) | 999 | |
| Overall Study | COMPLETED | Licensed Meningococcal Vaccine (19 to 55 Years) | 325 | |
| Overall Study | NOT COMPLETED | Novartis MenACWY Vaccine (11 to 18 Years) | 46 | |
| Overall Study | NOT COMPLETED | Licensed Meningococcal Vaccine (11 to 18 Years) | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events82
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 | Injection site pain | General disorders | Novartis MenACWY Vaccine | 1,106 | 2,649 | |
| other | Injection site pain | General disorders | Licensed Meningococcal Vaccine | 424 | 875 | |
| other | Injection site erythema | General disorders | Novartis MenACWY Vaccine | 414 | 2,649 | |
| other | Injection site erythema | General disorders | Licensed Meningococcal Vaccine | 126 | 875 | |
| other | Injection site induration | General disorders | Novartis MenACWY Vaccine | 324 | 2,649 | |
| other | Injection site induration | General disorders | Licensed Meningococcal Vaccine | 88 | 875 | |
| other | Chills | General disorders | Novartis MenACWY Vaccine | 169 | 2,649 | |
| other | Chills | General disorders | Licensed Meningococcal Vaccine | 50 | 875 | |
| other | Nausea | Gastrointestinal disorders | Novartis MenACWY Vaccine | 265 | 2,649 | |
| other | Nausea | Gastrointestinal disorders | Licensed Meningococcal Vaccine | 66 | 875 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Novartis MenACWY Vaccine | ||
| Total, all-cause mortality | Licensed Meningococcal Vaccine | ||
| Total, other adverse events | Novartis MenACWY Vaccine | 1,613 | 2,649 |
| Total, other adverse events | Licensed Meningococcal Vaccine | 572 | 875 |
| Total, serious adverse events | Novartis MenACWY Vaccine | 23 | 2,649 |
| Total, serious adverse events | Licensed Meningococcal Vaccine | 5 | 875 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | Trial comparisons |
| Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: 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/NCT00450437
GET https://conductscience.org/api/trials/v1/NCT00450437/results?page=2