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| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND 11278 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM(Ad+) | Experimental | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. |
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| MenACWY-CRM(Ad-) | Experimental | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. |
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| MenACWY- PS | Active Comparator | Subjects received one single dose of the polysaccharide vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM conjugate vaccine, adjuvanted | Biological |
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| MenACWY-CRM conjugate vaccine, unadjuvanted |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y | 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester | Minnesota | 55905 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19116603 | Background | Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J. 2009 Feb;28(2):86-91. doi: 10.1097/INF.0b013e31818a0237. | |
| 23114372 | Derived |
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All enrolled subjects were included in the trial.
Subjects were enrolled at Seattle, Washington; Pittsburgh, Pennsylvania; Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM(Ad+) | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. |
| FG001 | MenACWY-CRM(Ad-) | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Biological |
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| MenACWY polysaccharide vaccine | Biological |
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| 1 month after vaccination |
| Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | 12 months after vaccination |
| hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | 12 months after vaccination |
| Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. | Day 1 to Day 7 |
| Pittsburgh |
| Pennsylvania |
| 15241 |
| United States |
| Seattle | Washington | 98101 | United States |
| Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38. |
| FG002 | MenACWY-PS | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM(Ad+) | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. |
| BG001 | MenACWY-CRM(Ad-) | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. |
| BG002 | MenACWY-PS - Stage 1 | Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme). |
| BG003 | MenACWY-PS -Stage 2 | Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y | Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentages Of Subjects | 1 month after vaccination |
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| Secondary | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y. | Analysis was done on per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month after vaccination |
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| Secondary | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentages Of Subjects | 12 months after vaccination |
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| Secondary | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 12 months after vaccination |
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| Secondary | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. | Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data. | Posted | Number | Subjects | Day 1 to Day 7 |
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All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
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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(Ad+) | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | 4 | 164 | 123 | 164 | ||
| EG001 | MenACWY-CRM(Ad-) | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | 2 | 151 | 126 | 151 | ||
| EG002 | MenACWY-PS - Stage 1 | Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme). | 5 | 170 | 128 | 170 | ||
| EG003 | MenACWY-PS -Stage 2 | Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme). | 2 | 39 | 31 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cellulitis Pharyngeal | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Wound Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hand Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arachnoid Cyst | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hallucination, Auditory | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| Male |
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| MenW (N=161,146,173) |
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| MenY (N=159, 147,177) |
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| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine. | Chi-squared | <0.001 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine. | Chi-squared | <0.001 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine. | Chi-squared | 0.003 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine. | Chi-squared | <0.001 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine. | Chi-squared | 0.071 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine. | Chi-squared | <0.001 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine. | Chi-squared | <0.001 | 95 | Non-Inferiority or Equivalence | Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. |
| Participants |
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Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
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