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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023523-23 | EudraCT Number |
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This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCWY+OMV | Experimental | Subjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus Outer Membrane Vesicles (OMV) administered two months apart. |
|
| ABCWY+qOMV | Experimental | Subjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus one quarter dose of Outer Membrane Vesicles (qOMV) administered two months apart. |
|
| rMenB+OMV | Active Comparator | Subjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart. |
|
| MenACWY | Active Comparator | Subjects in this group received a dose of placebo followed by one dose of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine" administered two months later. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. | Biological | Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as:
Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA). | One month after the second vaccination (Day 91) |
| Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. | The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation. | One month after the second vaccination (Day 91) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine. | Day 1 and one month after second vaccination (Day 91) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615 | Birmingham | Alabama | 35205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29329168 | Derived | Szenborn L, Block SL, Jackowska T, Konior R, D'Agostino D, Smolenov I, Toneatto D, Welsch JA. Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study. Pediatr Infect Dis J. 2018 May;37(5):475-482. doi: 10.1097/INF.0000000000001896. |
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All enrolled subjects were included in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABCWY+OMV | Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart. |
| FG001 | ABCWY+qOMV | Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
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| Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. | Biological | Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. |
|
| Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. | Biological | One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
|
| Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV. | Biological | Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV. |
|
| The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine. | Day 1 and one month after the second vaccination (Day 91) |
| Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | Day 1 and one month after the second vaccination (Day 91) |
| Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. 4-fold increase is defined as follows; for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase. | One month after the second vaccination (Day 91) |
| The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | Day 1 and one month after the second vaccination (Day 91) |
| The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | One month after the second vaccination/prevaccination (Day 91/day 1) |
| The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY. | Day 1 through day 7 after any vaccination |
| The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY. | Throughout the study ( Day 1 to Day 241) |
| Madera Family Medical Group,1111 West 4th Street |
| Madera |
| California |
| 93637 |
| United States |
| Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301 | Paramount | California | 90723 | United States |
| Kentucky Pediatric/Adult Research, 201 south 5th street | Bardstown | Kentucky | 40004 | United States |
| Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2 | Louisville | Kentucky | 40291 | United States |
| Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C | Huber Heights | Ohio | 45424 | United States |
| Ohio Pediatric Research Association, 1775 Delco Park Drive | Kettering | Ohio | 45420 | United States |
| Focus Research Group,201 Signature Place | Lebanon | Tennessee | 37087 | United States |
| Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41 | Izabelin (Warszawa) | 05-080 | Poland |
| NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12 | Krakow | 31-223 | Poland |
| NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15 | Krakow | 31-422 | Poland |
| Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80 | Warsaw | 01-809 | Poland |
| Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44 | Wroclaw | 50-354 | Poland |
| FG002 | rMenB +OMV | Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart. |
| FG003 | ACWY | Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later. |
| COMPLETED |
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| NOT COMPLETED |
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Anaysis was done on the All Enrolled Population, ie, all subjects who signed an informed consent/assent, undergone screening procedure(s) and were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | ABCWY+OMV | Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart. |
| BG001 | ABCWY+qOMV | Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. |
| BG002 | rMenB +OMV | Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart. |
| BG003 | ACWY | Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later. |
| 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 | 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 a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as:
Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA). | Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after the second vaccination (Day 91) |
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| Primary | Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. | The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation. | Analysis was done on the Per Protocol Set - desirability, ie, all subjects who : correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding. | Posted | Number | Desirability index | One month after the second vaccination (Day 91) |
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| Secondary | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine. | Analysis was done on the per protocol population, immunogenicity. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 and one month after second vaccination (Day 91) |
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| Secondary | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine. | Analysis was done on the per protocol population, immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1 and one month after the second vaccination (Day 91) |
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| Secondary | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | Analysis was done on the per-protocol population, immunogenicity | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 and one month after the second vaccination (Day 91) |
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| Secondary | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. 4-fold increase is defined as follows; for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase. | Analysis was done on the per-protocol population, immunogenicity. | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after the second vaccination (Day 91) |
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| Secondary | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | Analysis was done on the per-protocol population, immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1 and one month after the second vaccination (Day 91) |
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| Secondary | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. | Analysis was done on the per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Ratio | One month after the second vaccination/prevaccination (Day 91/day 1) |
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| Secondary | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY. | Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination. | Posted | Number | Participants | Day 1 through day 7 after any vaccination |
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| Secondary | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY. | Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data. | Posted | Number | Participants | Throughout the study ( Day 1 to Day 241) |
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| Post-Hoc | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B strains 44/76 and 5/99 at one month after second vaccination are calculated | Analysis was done on the per-protocol population, immunogenicity. This exploratory analysis was performed only on strains 44/76 and 5/99. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At baseline and one month after second vaccination (Day 91) |
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Solicited AEs were collected from Day 1to Day 7; unsolicited AEs and SAEs were collected throughout the study period (Day 1 to Day 241).
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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 | ABCWY+OMV | Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart. | 2 | 120 | 104 | 120 | ||
| EG001 | ABCWY+qOMV | Subjects in this group received two doses of rMenB (+ OMV_1/4th dose) +and MenACWY combination vaccine, administered two months apart. | 2 | 120 | 104 | 120 | ||
| EG002 | rMenB +OMV | Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart. | 1 | 120 | 111 | 120 | ||
| EG003 | ACWY | Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart. | 3 | 109 | 87 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| PERTUSSIS | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Non-systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Non-systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| SPERMATOCELE | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Injection site Erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site Induration | General disorders | MedDRA | Systematic Assessment |
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| Injection site Pain | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines | RegistryContactVaccinesUS@novartis.com |
| Male |
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| Men C |
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| Men W-135 |
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| Men Y |
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| Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+OMV - ACWY) | 32 | 2-Sided | 95 | 21 | 44 | Non-Inferiority or Equivalence (legacy) | The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+OMV - ACWY) | 15 | 2-Sided | 95 | 0 | 30 | Non-Inferiority or Equivalence (legacy) | The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+OMV - ACWY) | 18 | 2-Sided | 95 | 5 | 31 | Non-Inferiority or Equivalence (legacy) | The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+qOMV - ACWY) | 18 | 2-Sided | 95 | 7 | 30 | Non-Inferiority or Equivalence (legacy) | The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+qOMV - ACWY) | 30 | 2-Sided | 95 | 18 | 42 | Non-Inferiority or Equivalence (legacy) | The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+qOMV - ACWY) | 19 | 2-Sided | 95 | 4 | 33 | Non-Inferiority or Equivalence (legacy) | The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination. |
| Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine. | Group Difference % (ABCWY+qOMV - ACWY) | 15 | 2-Sided | 95 | 3 | 29 | Non-Inferiority or Equivalence (legacy) | The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days. |
| OG001 |
| ABCWY+qOMV |
Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. |
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| ACWY |
Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later. |
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