Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| V59_57 | Other Identifier | Novartis Vaccines | |
| 2011-004421-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 through 5 years (1 Vac) MenACWY-CRM 1 | Placebo Comparator | Subjects 2 through 5 years received one vaccination of MenACWY-CRM |
|
| 2 through 5 years (2 Vac) MenACWY-CRM 2 | Active Comparator | Subjects 2 through 5 years received two vaccinations of MenACWY-CRM |
|
| 6 through 10 years (1 Vac) MenACWY-CRM 3 | Placebo Comparator | Subjects 6 through 10 years received one vaccination of MenACWY-CRM |
|
| 6 through 10 years (2 Vac) MenACWY-CRM 4 | Active Comparator | Subjects 6 through 10 years received two vaccinations of MenACWY-CRM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. | One Month After Last Vaccination ( day 86) |
| Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. | One Month After Last Vaccination (day 86) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM. | One Month After Last Vaccination (day 86) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unwilling or unable to give written informed assent or consent to participate in the study.
Perceived to be unreliable or unavailable for the duration of the study period.
Previous confirmed or suspected disease caused by N. meningitidis.
Previously immunized with a meningococcal vaccine (licensed or investigational).
Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
(certain exceptions influenza vaccines apply)
Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26398741 | Derived | Johnston W, Essink B, Kirstein J, Forleo-Neto E, Percell S, Han L, Keshavan P, Smolenov I. Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age. Pediatr Infect Dis J. 2016 Jan;35(1):e19-27. doi: 10.1097/INF.0000000000000931. |
Not provided
Not provided
All enrolled subjects were included in the trial.
Subjects were enrolled at 22 locations
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2 Through 5 Years (2 Vac) | Subjects 2-5 years of age received two MenACWY-CRM vaccinations |
| FG001 | 2 Through 5 Years (1 Vac) | Subjects 2-5 years of age received one MenACWY-CRM vaccination |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM. | One Month After Last Vaccination (day 86) |
| Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM. | One year after one vaccination or two vaccinations (day 422). |
| Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM. | One year after one vaccination or two vaccinations (day 422). |
| Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM | From Days 1-7 after each vaccination |
| Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM | From Days 1-7 after each vaccination |
| Number of Subjects Who Reported Selected AEs After Any Vaccination | Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM | Day 1 to Day 86 |
| Number of Subjects Who Reported Selected AEs After Any Vaccination | Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM | Day 1 to Day 422 |
| Sacramento |
| California |
| 95822 |
| United States |
| GSK Investigational Site | Lake Mary | Florida | 32746 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30189 | United States |
| GSK Investigational Site | Council Bluffs | Iowa | 51503 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40291 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Niles | Michigan | 49120 | United States |
| GSK Investigational Site | Stevensville | Michigan | 49127 | United States |
| GSK Investigational Site | Bellevue | Nebraska | 68005 | United States |
| GSK Investigational Site | Fremont | Nebraska | 68025 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Johnson City | New York | 13790 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44121 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44122 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76135 | United States |
| GSK Investigational Site | West Jordan | Utah | 84088 | United States |
| FG002 | 6 Through 10 Years (2 Vac) | Subjects 6-10 years of age received two MenACWY-CRM vaccinations |
| FG003 | 6 Through 10 Years (1 Vac) | Subjects 6-10 years of age received one MenACWY-CRM vaccination |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2 Through 5 Years (2 Vac) | Subjects 2-5 years of age received two MenACWY-CRM vaccinations |
| BG001 | 2 Through 5 Years (1 Vac) | Subjects 2-5 years of age received one MenACWY-CRM vaccination |
| BG002 | 6 Through 10 Years (2 Vac) | Subjects 6-10 years of age received two MenACWY-CRM vaccinations |
| BG003 | 6 Through 10 Years (1 Vac) | Subjects 6-10 years of age received one MenACWY-CRM vaccination |
| BG004 | 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 | year |
| |||||||||||||||
| 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 | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. | Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | One Month After Last Vaccination ( day 86) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. | Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | One Month After Last Vaccination (day 86) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM. | Analysis was done on the primary PP dataset. | Posted | Number | 95% Confidence Interval | percentage of subjects | One Month After Last Vaccination (day 86) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM. | Analysis was done on the primary PP dataset | Posted | Geometric Mean | 95% Confidence Interval | Titer | One Month After Last Vaccination (day 86) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM. | Analysis was done on the persistence PP dataset | Posted | Number | 95% Confidence Interval | percentages of subjects | One year after one vaccination or two vaccinations (day 422). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM. | Analysis was done on the persistence PP dataset | Posted | Geometric Mean | 95% Confidence Interval | Titers | One year after one vaccination or two vaccinations (day 422). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM | Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | subjects | From Days 1-7 after each vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM | Analysis was done on the safety dataset | Posted | Number | Subjects | From Days 1-7 after each vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Reported Selected AEs After Any Vaccination | Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM | Analysis was done on Safety Set Unsolicited AEs | Posted | Number | Subjects | Day 1 to Day 86 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Reported Selected AEs After Any Vaccination | Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM | Analysis was done on safety set | Posted | Number | Subjects | Day 1 to Day 422 |
|
Throughout study period
Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.
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 | 2 Through 5 Years (2 Vac) | Subjects 2-5 years of age received two MenACWY-CRM vaccinations | 2 | 179 | 148 | 179 | ||
| EG001 | 2 Through 5 Years (1 Vac) | Subjects 2-5 years of age received one MenACWY-CRM vaccination | 1 | 179 | 142 | 179 | ||
| EG002 | 6 Through 10 Years (2 Vac) | Subjects 6-10 years of age received two MenACWY-CRM vaccinations | 1 | 181 | 153 | 181 | ||
| EG003 | 6 Through 10 Years (1 Vac) | Subjects 6-10 years of age received one MenACWY-CRM vaccination | 1 | 174 | 133 | 174 | ||
| EG004 | Total | Total Population | 5 | 713 | 576 | 713 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IMMUNE THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 15.0v | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.0v | Systematic Assessment |
| |
| PETIT MAL EPILEPSY | Nervous system disorders | MedDRA 15.0v | Systematic Assessment |
| |
| INTERMITTENT EXPLOSIVE DISORDER | Psychiatric disorders | MedDRA 15.0v | Systematic Assessment |
| |
| OPPOSITIONAL DEFIANT DISORDER | Psychiatric disorders | MedDRA 15.0v | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 15.0v | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.0v | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 15.0v | Systematic Assessment |
| |
| INJECTION SITE INDURATION | General disorders | MedDRA 15.0v | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 15.0v | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.0v | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 15.0v | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0v | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0v | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0v | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.0v | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 15.0v | Systematic Assessment |
| |
| EATING DISORDER | Psychiatric disorders | MedDRA 15.0v | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA 15.0v | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0v | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0v | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
Not provided
Not provided
Not provided
| Male |
|
| MenC(N=131,140,149,142) |
|
| MenW(N=128,135,148,138) |
|
| MenY(N=128,133,148,142) |
|
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC | MN method | Vaccine Group Differences at Day 86 | 27 | 2-Sided | 97.5 | 16.9 | 37.7 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC |
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW | MN method | Vaccine Group Differences at Day 86 | 14 | 2-Sided | 97.5 | 1.4 | 26.7 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW |
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY | MN method | Vaccine Group differences at Day 86 | 27 | 2-Sided | 97.5 | 15.6 | 37.6 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y |
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA | MN method | Vaccines Group Differences at Day 86 | 11 | 2-Sided | 97.5 | 1.7 | 21.3 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA |
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC | MN method | Vaccines Group differences at Day 86 | 19 | 2-Sided | 97.5 | 9.9 | 29.2 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC |
| Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW | MN method | Vaccines Group Differences at Day 86 | 4 | 2-Sided | 97.5 | -8.6 | 17.4 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW |
| Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY | MN method | Vaccines Group Differences at Day 86 | 29 | 2-Sided | 97.5 | 18.4 | 40 | Non-Inferiority or Equivalence | Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY |
Subjects 6-10 years of age received two MenACWY-CRM vaccinations |
| OG003 | 6 Through 10 Years (1 Vac) | Subjects 6-10 years of age received one MenACWY-CRM vaccination |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|