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MenACWY-CRM+ MMRV · 3 trials · 2 indications
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported. Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella. Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).
Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA). The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.
The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM (1 dose) | EXPERIMENTAL | 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. |
| Licensed polysaccharide vaccine | ACTIVE_COMPARATOR | 1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 |
| MenACWY-CRM (2 doses) | EXPERIMENTAL | 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61. |
| MenACWY-CRM+ MMRV | EXPERIMENTAL | - |
| MMRV | ACTIVE_COMPARATOR | - |
| MenACWY-CRM | EXPERIMENTAL | - |
| Licensed Meningococcal Vaccine | ACTIVE_COMPARATOR | Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine |
| Novartis MenACWY Conjugate Vaccine | EXPERIMENTAL | Novartis meningococcal ACWY conjugate Vaccine |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM | BIOLOGICAL | 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly |
| Licensed meningococcal ACWY vaccine | BIOLOGICAL | 1 injection of the licensed meningococcal ACWY was administered intramuscularly |
| MenACWY-CRM + MMRV | BIOLOGICAL | One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age. |
| MMRV | BIOLOGICAL | one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age |
| MenACWY CRM | BIOLOGICAL | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly. |
| Meningococcal ACWY Conjugate vaccine | BIOLOGICAL | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly. |
Inclusion Criteria: * healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent * who are available for all visits and telephone calls scheduled for the study * who are up-to-date ...
MenACWY-CRM is an investigational vaccine being developed for the prevention of meningococcal disease, including meningococcal meningitis and other meningococcal infections. It is designed to protect against serogroups A, C, W, and Y of the Neisseria meningitidis bacteria.
MenACWY-CRM is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
MenACWY-CRM is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All eight clinical trials listed for MenACWY-CRM have been completed, with no active trials currently ongoing.
MenACWY-CRM has been studied in several completed clinical trials, including NCT00262028, NCT00488683, NCT00560313, and NCT01994629. These trials evaluated the safety and immune response of the vaccine in healthy children, infants, and adults across the United States, United Kingdom, and Italy.
MenACWY-CRM is a conjugate vaccine that works by stimulating the immune system to produce antibodies against the Neisseria meningitidis bacteria. It targets the bacterial capsular polysaccharides of serogroups A, C, W, and Y, which are chemically linked to a carrier protein to enhance the immune response.
MenACWY-CRM is also known as Menveo, a meningococcal ACWY conjugate vaccine. The name MenACWY-CRM refers to the CRM197 carrier protein used in the vaccine. This vaccine is designed to prevent invasive meningococcal disease caused by serogroups A, C, W, and Y.