Trial · NCT00329849
Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
NCT00329849, Phase 3, Completed, Novartis Vaccines; results first posted 2013-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age. Trials, record NCT00329849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00329849
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
- NCT number
- NCT00329849
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,500 participants, actual
- Lead sponsor
- Novartis Vaccines
- Conditions
- Meningococcal Disease
- Interventions
- Meningococcal ACWY-CRM conjugate vaccine, Meningococcal ACWY-PS polysaccharide vaccine
- First posted
- 2006-05-25
- Last updated
- 2018-10-09
- Results first posted
- 2013-11-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | 1 month after vaccination (day 29) | Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer. |
| Primary | Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | Day 1 to 7 postvaccination | Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination. |
| Secondary | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS. |
| Secondary | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS. |
| Secondary | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS. |
| Secondary | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS |
| Secondary | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 to 7 postvaccination | Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | 1 month after vaccination (day 29) | Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan. | Percentage of subjects | NUMBER |
| PRIMARY | Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | Day 1 to 7 postvaccination | Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data. | Number of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | Analysis was performed on the PP dataset of primary vaccination. | Percentage of subjects | NUMBER |
| SECONDARY | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | Analysis was performed on the PP dataset of primary vaccination. | Geometric Mean Titers | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | Analysis was performed on PP dataset for persistence analysis at day 181. | Percentage of subjects | NUMBER |
| SECONDARY | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | Analysis was performed on the PP dataset for persistence analysis at day 181. | Geometric Mean Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 to 7 postvaccination | Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group182
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-CRM | Serogroup A | 93 | 95% Confidence Interval 87 to 96 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-PS | Serogroup A | 55 | 95% Confidence Interval 46 to 63 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-CRM | Serogroup C (N=147,144) | 82 | 95% Confidence Interval 74 to 88 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-PS | Serogroup C (N=147,144) | 52 | 95% Confidence Interval 44 to 60 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-CRM | Serogroup W (N=143,142) | 74 | 95% Confidence Interval 66 to 81 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-PS | Serogroup W (N=143,142) | 46 | 95% Confidence Interval 37 to 54 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-CRM | Serogroup Y (N=146,146) | 82 | 95% Confidence Interval 74 to 87 | Percentage of subjects |
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | MenACWY-PS | Serogroup Y (N=146,146) | 63 | 95% Confidence Interval 55 to 71 | Percentage of subjects |
| Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | MenACWY-CRM | 11 | Number of subjects | ||
| Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | MenACWY-PS | 1 | Number of subjects |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MenACWY-CRM | 950 | |
| Overall Study | STARTED | MenACWY-PS | 550 | |
| Overall Study | COMPLETED | MenACWY-CRM | 944 | |
| Overall Study | COMPLETED | MenACWY-PS | 546 | |
| Overall Study | NOT COMPLETED | MenACWY-CRM | 6 | |
| Overall Study | NOT COMPLETED | MenACWY-PS | 4 |
Source ClinicalTrials.gov
Adverse events26
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 | MenACWY-CRM | 221 | 950 | 221 |
| other | Injection site pain | General disorders | MenACWY-PS | 168 | 550 | 168 |
| other | Injection site erythema | General disorders | MenACWY-CRM | 166 | 950 | 166 |
| other | Injection site erythema | General disorders | MenACWY-PS | 71 | 550 | 71 |
| other | Headache | Nervous system disorders | MenACWY-CRM | 125 | 950 | 125 |
| other | Headache | Nervous system disorders | MenACWY-PS | 72 | 550 | 72 |
| other | Injection site induration | General disorders | MenACWY-CRM | 143 | 950 | 143 |
| other | Injection site induration | General disorders | MenACWY-PS | 61 | 550 | 61 |
| other | Pyrexia | General disorders | MenACWY-CRM | 75 | 950 | 75 |
| other | Pyrexia | General disorders | MenACWY-PS | 49 | 550 | 49 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MenACWY-CRM | ||
| Total, all-cause mortality | MenACWY-PS | ||
| Total, other adverse events | MenACWY-CRM | 409 | 950 |
| Total, other adverse events | MenACWY-PS | 271 | 550 |
| Total, serious adverse events | MenACWY-CRM | 9 | 950 |
| Total, serious adverse events | MenACWY-PS | 1 | 550 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19895922 | RESULT |
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 |
|---|
| MenACWY-CRM vs MenACWY-PS: 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/NCT00329849
GET https://conductscience.org/api/trials/v1/NCT00329849/results?page=2