Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Menveo, MenACWY-CRM
Meningococcal ACWY conjugate vaccine · 17 trials · 8 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
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
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.
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
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.
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.
Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
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.
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
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)
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM | EXPERIMENTAL | MenACWY-CRM |
| MenACWY - 2 - 10 Years old | EXPERIMENTAL | Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1. |
| MenACWY - 11 - 18 Years old | EXPERIMENTAL | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
| MenACWY - 19 - 75 Years old | EXPERIMENTAL | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
| 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. |
| 2-18 years | EXPERIMENTAL | - |
| 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-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 | - |
| US1A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US1B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US2 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US3 (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4A (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4B (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| US4C (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA1A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA1B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA2 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA3A (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA3B (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA4 (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA5 (MenACWY-CRM + Infant Vaccines) | EXPERIMENTAL | Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6A (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6B (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| LA6C (Infant Vaccines Only) | EXPERIMENTAL | Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
| Licensed Meningococcal Vaccine | ACTIVE_COMPARATOR | Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine |
| Novartis MenACWY Conjugate Vaccine | EXPERIMENTAL | Novartis meningococcal ACWY conjugate Vaccine |
| Tdap + MenACWY-CRM | EXPERIMENTAL | Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms |
| Tdap + saline | EXPERIMENTAL | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| MenACWY-CRM + saline | EXPERIMENTAL | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| 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) |
| MenACWY-CRM (2-10 years) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-CRM (12-23 months) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-PS (2-10 years) | ACTIVE_COMPARATOR | Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine |
| MenACWY-CRM+PnC (12-15 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC |
| MenACWY-CRM+DTaP (16-23 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM | BIOLOGICAL | 1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection |
| Meningococcal ACWY conjugate vaccine | BIOLOGICAL | All subjects received a single dose of Meningococcal ACWY conjugate vaccine |
| 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. |
| 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 |
| DTaP-IPV-HBV | BIOLOGICAL | - |
| Hib | BIOLOGICAL | - |
| Rotavirus | BIOLOGICAL | - |
| Pneumococcal 7-valent Conjugate Vaccine | BIOLOGICAL | - |
| HAV | BIOLOGICAL | - |
| MMR-V | BIOLOGICAL | - |
| DTaP | BIOLOGICAL | - |
| MenACWY CRM | BIOLOGICAL | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly. |
| Meningococcal ACWY conjugate vaccine (MenACWY-CRM) | BIOLOGICAL | - |
| Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap) | BIOLOGICAL | - |
| saline placebo | BIOLOGICAL | 4.5 mg sodium chloride per 0.5 ml dose |
| 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. |
| 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 | - |
| MenACWY-CRM Vaccine | BIOLOGICAL | - |
| MenACWY-PS Vaccine | 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...
The Meningococcal ACWY conjugate vaccine is used to help prevent meningococcal disease, including bacterial meningitis and meningococcal meningitis. It is designed to protect against meningococcal serogroups A, C, W, and Y. Clinical studies have evaluated it in healthy subjects ranging from 2 months to 75 years of age.
The Meningococcal ACWY conjugate vaccine is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the Phase 3 clinical program evaluating the vaccine across multiple countries, including the United States, Argentina, Colombia, India, Taiwan, and Italy.
The Meningococcal ACWY conjugate vaccine has been studied in Phase 3 clinical trials. All four of its registered studies are listed as completed, and no trials are currently active. It is an investigational vaccine that has been evaluated in controlled Phase 3 studies.
Four completed Phase 3 trials have evaluated the Meningococcal ACWY conjugate vaccine: NCT00474526 in infants across the United States, Argentina, and Colombia; NCT00329901 in subjects aged 11 to 25 in Italy; NCT01547715 in India; and NCT01410474 in Taiwan. Together these studies enrolled more than 6,000 participants.
Yes, MenACWY-CRM is another name for the Meningococcal ACWY conjugate vaccine. The MenACWY-CRM designation refers to the CRM197 carrier protein conjugate formulation. Both names describe the same Novartis vaccine candidate evaluated in the completed Phase 3 clinical program.