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In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM (≥7-≤10 years of age) | Experimental | Subjects, who had previously received 2 injections of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. |
|
| MenACWY-CRM_1 (≥7-≤10 years of age) | Experimental | Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. |
|
| Vaccine naive (≥7-≤10 years of age) | Experimental | Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
|
| MenACWY-CRM_1 (≥11-≤15 years of age) | Experimental | Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 7-10 years of age, were administered 1 injection of the same vaccine at 11-15 years of age. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine | Biological | Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA). | 5 years post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. | 5 years post-vaccination |
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Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.
If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.
Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.
A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
For subjects who participated in study V59P20 (Groups MenACWYCRM_ 2 (≥7-≤10 Years), MenACWYCRM_1 (≥7-≤10 Years) and MenACWYCRM_ 1 (≥11-≤15 Years) only):
For vaccine-naive subjects (Groups Vaccine Naive(≥7-≤10Years) and Vaccine Naive (≥11-≤15 Years) only):
Exclusion Criteria:
In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 82 Children s Inv Research Prgm (ChIRP) 2900 Medical Center Parkway, Ste. 300 | Bentonville | Arkansas | 72712 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20943209 | Background | Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29. |
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All subjects were included in the trial.
Subjects were recruited from 22 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM_2 (≥7-≤10 Years) | Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. |
| FG001 | MenACWY-CRM_1 (≥7-≤10 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vaccine naive (≥11-≤15 years of age) | Experimental | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
|
| Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects. | 5 years post-vaccination; baseline for naive |
| Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8. | Day 28 post-vaccination |
| Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs. | Day 28 post-vaccination |
| Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,
| Day 1 to day 7 post-vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal. | Day 1 to day 28 |
| 83 AR Pediatric Clinical Research 500 South University, Ste. 200 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| 32 Prem Health Research Center 9317 Firestone Blvd. | Downey | California | 90241 | United States |
| 27 KY Pediatric Adult Research 201 South 5th Street, Suite 102 | Bardstown | Kentucky | 40004 | United States |
| 36 Meridian Clinical Research 3319 N. 107th Street | Omaha | Nebraska | 68134 | United States |
| 33 Dr. Sender's and Associates 2054 South Green Road | Cleveland | Ohio | 44121 | United States |
| 31 Benchmark Research, Fort Worth 4504 Boat Club Rd., Suite 400A | Fort Worth | Texas | 76135 | United States |
| 25 Benchmark Research, San Angelo 3555 Knickerbocker Rd. | San Angelo | Texas | 76904 | United States |
| 65 Westside Medical 1477 N 2000 W, Suite C | Clinton | Utah | 84015 | United States |
| 29 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100 | Salt Lake City | Utah | 84121 | United States |
| 30 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100 | Salt Lake City | Utah | 84121 | United States |
| 37 Copperview Medical Associates 3556 West 9800 South | South Jordan | Utah | 84095 | United States |
| 47 Wee Care Pediatrics 1792 W. 1700 S. | Syracuse | Utah | 84075 | United States |
| 34 Rockwood Clinic P S 400 East Fifth Avenue | Spokane | Washington | 99202 | United States |
| 35 Rockwood Clinic-North Pediatrics 9001 N Country Homes Blvd | Spokane | Washington | 99218 | United States |
| 26 Benchmark Research 3800 Houma Blvd., Suite 345 | Metairie | LA | 70006 | Ukraine |
Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. |
| FG002 | Vaccine Naive (≥7-≤10 Years) | Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine. |
| FG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| FG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
| FG005 | Not Assigned | Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate "not assigned" group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7-≤10 Years) group in the extension study. |
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| NOT COMPLETED |
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Analysis was done on the all enrolled population.
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM_2 (≥7-≤10 Years) | Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. |
| BG001 | MenACWY-CRM_1 (≥7-≤10 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. |
| BG002 | Vaccine Naive (≥7-≤10 Years) | Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine. |
| BG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| BG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
| BG005 | Not Assigned | Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate "not assigned" group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7-≤10 Years) group in the extension study. |
| BG006 | 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 Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA). | The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 5 years post-vaccination |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. | The analysis was done on per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 5 years post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects. | The analysis was done on per-protocol population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 5 years post-vaccination; baseline for naive |
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| Secondary | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8. | The analysis was done on per-protocol population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs. | The analysis was done on per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,
| The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data. | Posted | Number | Number of subjects | Day 1 to day 7 post-vaccination |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal. | The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data. | Posted | Number | Number of subjects | Day 1 to day 28 |
|
All solicited AE were collected from day 1 to day 7; unsolicited AEs, AE's leading to premature withdrawal and all Serious Adverse Events were collected throughout the study (day1 to day 28).
All solicited AEs are reported as systematic assessment ; all unsolicited AEs are reported as non-systematic assessment.
Serious adverse events analysis was done on the unsolicited safety set, other adverse events analysis was done on the overall safety set.
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| 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_2 (≥7-≤10 Years) | Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. | 0 | 73 | 48 | 73 | ||
| EG001 | MenACWY-CRM_1 (≥7-≤10 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. | 0 | 102 | 70 | 102 | ||
| EG002 | Vaccine Naive (≥7-≤10 Years) | Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine. | 1 | 120 | 77 | 120 | ||
| EG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. | 0 | 65 | 46 | 65 | ||
| EG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. | 1 | 100 | 66 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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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 |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| Male |
|
|
| Serogroup W (N= 69, 96, 64) |
|
| Serogroup Y |
|
|
|
| OG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| OG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
|
|
| OG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| OG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
|
|
| OG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| OG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
|
|
| OG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| OG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
|
|
| OG003 | MenACWY-CRM_1 (≥11-≤15 Years) | Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. |
| OG004 | Vaccine Naive (≥11-≤15 Years) | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. |
|
|