Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM | Experimental | Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. |
|
| Licensed comparator | Active Comparator | Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination. |
|
| Naive | Other | Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. |
|
| MenACWY-CRM/MenACWY-CRM | Experimental | Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
|
| Licensed comparator/MenACWY-CRM | Experimental | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM conjugate vaccine | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y. | 21 months, 3 years and 5 years postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y. |
Not provided
Inclusion Criteria:
Subjects enrolled in V59P13:
Naïve subjects:
Exclusion Criteria:
Subjects who had completed the V59P13 study:
Naïve subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615 | Birmingham | Alabama | 35205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21339701 | Result | Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo(R)) or Menactra(R) among healthy adolescents. Hum Vaccin. 2010 Nov;6(11):881-7. doi: 10.4161/hv.6.11.12849. Epub 2010 Nov 1. |
Not provided
Not provided
All enrolled subjects were included in the trial.
Subjects were recruited from 19 sites in US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM | Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. |
| FG001 | Licensed Comparator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Licensed comparator |
| Biological |
|
|
| 21 months, 3 years and 5 years postvaccination |
| hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y. | 21 months, 3 years and 5 years postvaccination |
| Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 | Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | day 1 |
| hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination | Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y. | day 1 |
| Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine | Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | 1 month post booster vaccination |
| Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine | Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | 2 years postvaccination |
| Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine | Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y. | 2 years postvaccination |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events | Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point. | Day 1 to Day 7 |
| Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator | Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine. | Day 1 to 5 years |
| Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine. | 28 days postvaccination |
| 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway |
| Fremont |
| California |
| 94538 |
| United States |
| 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor | Fresno | California | 93726 | United States |
| 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB | Hayward | California | 94545 | United States |
| Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor | Oakland | California | 94612 | United States |
| 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies | Roseville | California | 95661 | United States |
| 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C | Sacramento | California | 95823 | United States |
| Kaiser Permanente, 6600 Bruceville Rd. | Sacramento | California | 95823 | United States |
| 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1 | San Jose | California | 95119 | United States |
| 2 PAMPA 2155 Post Oak Tritt Road, Suite 100 | Marietta | Georgia | 30062 | United States |
| 3 PAMPA 120 Stonebridge Parkway Ste. 410 | Woodstock | Georgia | 30189 | United States |
| 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102 | Bardstown | Kentucky | 40004 | United States |
| 38 Akron Children's Hospital One Perkins Square | Akron | Ohio | 44308 | United States |
| 43 Dr. Senders and Associates 2054 South Green Road | South Euclid | Ohio | 44121 | United States |
| 19 Children's Health Care West 4671 West Lake Road | Erie | Pennsylvania | 16505 | United States |
| 21 Greenville Medical Centre Inc 90 Shenango Street | Greenville | Pennsylvania | 16125 | United States |
| 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue | Grove City | Pennsylvania | 16127 | United States |
| 23 Pediatric Associates of Latrobe 210 Weldon Street | Latrobe | Pennsylvania | 15650 | United States |
| 14 Squirrel Hill Office 4070 Beechwood Blvd | Pittsburgh | Pennsylvania | 15217 | United States |
| 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100 | Pittsburgh | Pennsylvania | 15220 | United States |
| 15 South Hills Pediatrics 4411 Stilley Road | Pittsburgh | Pennsylvania | 15227 | United States |
| 13 Pediatric Alliance Southwestern 850 Clairton Blvd. | Pittsburgh | Pennsylvania | 15236 | United States |
| 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120 | Pittsburgh | Pennsylvania | 15237 | United States |
| 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | 15241 | United States |
| Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | 15241 | United States |
| 35 Pennridge Pediatric Associates 711 Lawn Avenue | Sellersville | Pennsylvania | 18960 | United States |
| 22 Laurel Pediatrics 140 Wayland Smith Drive | Uniontown | Pennsylvania | 15401 | United States |
| 25 Family Practice Medical Associates South 2581 Washington Road Suite 211 | Upper Saint Clair | Pennsylvania | 15241 | United States |
| PEAK Research, LLC, 2589 Washington Road, Suite 412B | Upper Saint Clair | Pennsylvania | United States |
| 47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H | Galveston | Texas | 77555 | United States |
| 56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100 | Salt Lake City | Utah | 84121 | United States |
| 45 Group Health Research Institute 1730 Minor Ave, Suite 1600 | Seattle | Washington | 98101 | United States |
Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
| FG002 | Naive | Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. |
| FG003 | MenACWY-CRM/MenACWY-CRM | Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| FG004 | Licensed Comparator /MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM | Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. |
| BG001 | Licensed Comparator | Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination. |
| BG002 | Naive | Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. |
| BG003 | MenACWY-CRM/MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination. |
| BG004 | Licensed Comparator /MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentages of subjects | 21 months, 3 years and 5 years postvaccination |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentages of subjects | 21 months, 3 years and 5 years postvaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | titers | 21 months, 3 years and 5 years postvaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 | Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentages of subjects | day 1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination | Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | titers | day 1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine | Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentages of subjects | 1 month post booster vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine | Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentages of subjects | 2 years postvaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine | Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y. | Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | titers | 2 years postvaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Local and Systemic Adverse Events | Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point. | Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | subjects | Day 1 to Day 7 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator | Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine. | Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases. | Posted | Number | subjects | Day 1 to 5 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine | Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine. | Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up. | Posted | Number | subjects | 28 days postvaccination |
|
New medical diagnoses of chronic diseases in subjects who previously received MenACWY-CRM conjugate or Licensed comparator vaccine were collected from day 1 to 5 years. Medically attended AEs were collected within 28 days after vaccination at 5 years.
All SAEs reported during 24 hours from blood draw at the 5-year timepoint were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MenACWY-CRM | Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. | 0 | 284 | 0 | 284 | ||
| EG001 | Licensed Comparator | Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination. | 1 | 178 | 0 | 178 | ||
| EG002 | Naive | Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. | 0 | 343 | 0 | 343 | ||
| EG003 | MenACWY-CRM/MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination. | 0 | 83 | 55 | 83 | ||
| EG004 | Licensed Comparator /MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. | 1 | 77 | 49 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | medDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | medDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004168 | Diphtheria Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| 5 Years |
|
| Men C - 21 Months (N=102, 59) |
|
| 3 Years (N=102, 59) |
|
| 5 Years (N=102, 59) |
|
| MenW- 21 Months (N=101, 57) |
|
| 3 Years (N=101, 57) |
|
| 5 Years (N=101, 57) |
|
| MenY- 21 Months |
|
| Three Years |
|
| Five Years |
|
| Participants |
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
| OG003 | Licensed Comparator /MenACWY-CRM | Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination. |
|
|
|
|