Approval Probability
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Adjusted LOA
ML Risk
Meningococcal Group B vaccine · 2 trials · 2 indications
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 (NCT02199691) or MET43 (NCT02842853), received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). |
| Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) | EXPERIMENTAL | Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). |
| Group 3: MenACYW Conjugate vaccine + Trumenba vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). |
| Group 4: MenACYW Conjugate vaccine + Bexsero vaccine | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). |
| Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Group 3: Bexsero® (2, 4, and 12 to 13 Months) | ACTIVE_COMPARATOR | Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Name | Type | Description |
|---|---|---|
| Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: IM |
| Meningococcal Group B vaccine (Trumenba®) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Meningococcal group B vaccine (Bexsero®) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine | BIOLOGICAL | Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL |
| Meningococcal group B vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL |
| Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine | BIOLOGICAL | Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL |
| Human rotavirus RIX4414 strain vaccine | BIOLOGICAL | Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL |
| Pneumococcal 13-valent polysaccharide conjugate vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL |
Inclusion criteria : * Aged \>= 13 to less than (\<) 26 years on the day of inclusion. * Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only). * For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment...
Meningococcal Group B vaccine is used for meningococcal immunisation in healthy volunteers and for preventing meningococcal infection. It is being studied in healthy volunteers, including infants, toddlers, and adolescents, to evaluate immune responses and safety when administered alone or with other vaccines.
Sanofi (ticker: SNY) is developing Meningococcal Group B vaccine. The vaccine is currently in Phase 3 clinical development for meningococcal immunisation in healthy volunteers.
Meningococcal Group B vaccine is in Phase 3 clinical development. It is investigational and not yet approved. Two Phase 3 trials have been completed, studying the vaccine in healthy volunteers for meningococcal immunisation.
Meningococcal Group B vaccine has been studied in two completed Phase 3 trials. NCT03632720 evaluated a quadrivalent meningococcal conjugate vaccine in infants and toddlers in the United Kingdom. NCT04084769 evaluated a booster dose of a quadrivalent meningococcal conjugate vaccine in adolescents in the United States and Puerto Rico.
Meningococcal Group B vaccine is being studied alongside quadrivalent meningococcal conjugate vaccines. The clinical trials NCT03632720 and NCT04084769 involve quadrivalent meningococcal conjugate vaccines, and the Group B vaccine is evaluated for concomitant use or comparison in these studies.