Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bexsero · 2 trials · 2 indications
Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB\_0\_2 and ABCWY\_ 0\_2 Groups.
| Arm | Type | Description |
|---|---|---|
| Bexsero + Routine Group | EXPERIMENTAL | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. |
| Routine Group | ACTIVE_COMPARATOR | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
| rMenB_0_2 Group | EXPERIMENTAL | Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. |
| ABCWY_ 0_2 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. |
| ABCWY_0_1 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6. |
| ABCWY_0_6 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2. |
| ABCWY_0_11 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2. |
| ABCWY_0_2_6 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12. |
| Name | Type | Description |
|---|---|---|
| Bexsero® | BIOLOGICAL | Four doses administered in the anterolateral area of the right or left thigh. |
| Routine vaccines | BIOLOGICAL | Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh. |
| Bexsero | BIOLOGICAL | Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB\_0\_2 Group. |
| Saline Placebo | OTHER | One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group, Month 2 in ABCWY\_0\_6 Group and ABCWY\_0\_11 Group and Month 6 in ABCWY\_0\_1 Group. |
| Havrix | BIOLOGICAL | Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY\_0\_1 Group, Month 1 and 12 in Group ABCWY\_0\_6 Group and ABCWY\_0\_2\_6 Group , Month 0 and 6 in ABCWY\_0\_11 Group and Month 6 and 12 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group. |
| MenABCWY | BIOLOGICAL | Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY\_0\_1 Group, Month 0 and 6 in ABCWY\_0\_6 Group, Month 1 and 12 in ABCWY\_0\_11 Group, Month 0, 2 and 6 in ABCWY\_0\_2\_6 Group, Month 0 and 2 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group. |
Inclusion Criteria: 1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been...
Bexsero is a meningococcal group B vaccine used to prevent infections caused by Neisseria meningitidis group B, including meningococcal disease. It is being studied for use in infants, children, and adolescents to protect against invasive meningococcal infections.
Bexsero is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's portfolio of infectious disease products.
Bexsero is in clinical development, with completed trials in Phase 2 and Phase 3. It is not yet approved for use in all markets, and ongoing studies continue to evaluate its safety and immunogenicity in different age groups.
Bexsero has been studied in two completed trials: NCT02173704, a Phase 3 study in infants in Taiwan, and NCT02212457, a Phase 2 study in adolescents in the United States, Finland, and Poland. Both trials assessed safety and immunogenicity.
No, Bexsero is a meningococcal B vaccine, while the meningococcal ABCWY vaccine is a separate combination vaccine. In a Phase 2 trial, the ABCWY vaccine was compared to Bexsero to assess immunogenicity and safety in adolescents.