Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MenACWY-CRM · 9 trials · 4 indications
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.
The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y.
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\_12 M group)
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM | EXPERIMENTAL | MenACWY-CRM |
| Group 1 | ACTIVE_COMPARATOR | This group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' alone on the different visits. |
| Group 2 | ACTIVE_COMPARATOR | This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A \& recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM. |
| Group 3 | ACTIVE_COMPARATOR | This group will receive only MenACWY-CRM. |
| MenACWY (2 primary + 1 booster dose) | EXPERIMENTAL | Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. |
| MenACWY (1 primary + 1 booster dose) | EXPERIMENTAL | Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. |
| MenC (1 primary dose)+MenACWY (1 booster dose) | EXPERIMENTAL | Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study. |
| MenACWY3 | EXPERIMENTAL | Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age. |
| MenACWY4 | EXPERIMENTAL | All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4. |
| Routine Vaccines | PLACEBO_COMPARATOR | Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age. |
| MenACWY-CRM + Routine Vaccines | EXPERIMENTAL | Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months. |
| MenACWY-TT | ACTIVE_COMPARATOR | MenACWY-TT |
| MenACWY-CRM and Routine Vaccines (Group 1) | EXPERIMENTAL | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
| MenACWY-CRM and Routine Vaccines (Group 2) | EXPERIMENTAL | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. |
| MenACWY-CRM and Routine Vaccines (Group 3) | EXPERIMENTAL | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. |
| 4CMenB | EXPERIMENTAL | - |
| MenACWY CRM | EXPERIMENTAL | - |
| MenACWY-CRM_6-12 M | EXPERIMENTAL | Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) |
| MenACWY-CRM_12 M | EXPERIMENTAL | Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) |
| MenC-CRM_12 M_MenACWY-CRM_18 M | EXPERIMENTAL | Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months) |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM | BIOLOGICAL | 1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection |
| Combined inactivated hepatitis A & recombinant hepatitis B | BIOLOGICAL | Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects. |
| Recombinant hepatitis B vaccine | BIOLOGICAL | Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29 |
| Inactivated hepatitis A vaccine | BIOLOGICAL | Inactivated hepatitis A will be administered intramuscularly on days 8 and 29. |
| Routine Vaccines | BIOLOGICAL | Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides. |
| DTaP-IPV/Hib | BIOLOGICAL | IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh. |
| HBV | BIOLOGICAL | IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh. |
| PCV | BIOLOGICAL | IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh. |
| MMR | BIOLOGICAL | Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh. |
| MenACWY-TT | BIOLOGICAL | MenACWY-TT |
| DTaP-Hib-IPV | BIOLOGICAL | IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh. |
| Hib | BIOLOGICAL | IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh. |
| Men ACWY CRM | BIOLOGICAL | A single dose of a 0.5 mL injectable solution |
| 4CMenB | BIOLOGICAL | All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm. |
| MenC-CRM | BIOLOGICAL | One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region. |
| PC7 | BIOLOGICAL | One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh. |
| Varicella | BIOLOGICAL | - |
Inclusion Criteria: Individuals eligible for enrollment in this study were those: 1. Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and: * the parent/legal representative had provided written informed con...
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.