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Also known as Bexsero® vaccine (1 dose at study month zero)
Bexsero vaccine · 1 trial · 2 indications
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.
| Arm | Type | Description |
|---|---|---|
| 2H3H511_V | EXPERIMENTAL | In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study. |
| 2H3H511_NV | NO_INTERVENTION | In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. |
| 3H5_11_V | EXPERIMENTAL | In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. |
| 3H5_11_NV | NO_INTERVENTION | In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. |
| 68_11_V | EXPERIMENTAL | In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. |
| 68_11_NV | NO_INTERVENTION | In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. |
| 02_2_5_V | EXPERIMENTAL | In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. |
| 02_2_5_NV | NO_INTERVENTION | In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. |
| 02_6_10_V | EXPERIMENTAL | In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. |
| 02_6_10_NV | NO_INTERVENTION | In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. |
| NAIVE 123 | EXPERIMENTAL | Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. |
| NAIVE_4A | EXPERIMENTAL | Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. |
| NAIVE_4B | EXPERIMENTAL | Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. |
| Name | Type | Description |
|---|---|---|
| Bexsero® vaccine (1 dose at study month zero) | BIOLOGICAL | - |
| Bexsero® vaccine (2 doses 1 month apart) | BIOLOGICAL | - |
Inclusion Criteria: For naïve subjects newly enrolled: 1. Healthy infants and children according to the following age groups: 1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the d...
Bexsero vaccine is used for the prevention of meningococcal disease, including meningococcal meningitis. It is a vaccine developed for infectious disease prevention. Clinical study NCT01894919 evaluated antibody persistence and the safety and tolerability of a booster dose after completion of the vaccination course in children from 35 months of age.
Bexsero vaccine is developed by Novartis AG, which trades under the ticker NVS. The company sponsored the Phase 3 study NCT01894919, which enrolled 851 participants across Hungary and Spain to assess antibody persistence and booster dose safety.
Bexsero vaccine has been studied in Phase 3 clinical development. The Phase 3 trial NCT01894919 has been completed, and it enrolled 851 participants. The study was randomized and no-treatment controlled, and it included healthy volunteers aged 35 months and older.
Bexsero vaccine has been evaluated in the Phase 3 trial NCT01894919, titled Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28. The trial is completed and enrolled 851 participants in Hungary and Spain.
Yes, Bexsero vaccine is also referred to as Bexsero® vaccine (1 dose at study month zero). This alternative name reflects the dosing schedule used in clinical study NCT01894919, which evaluated a booster dose after the initial vaccination course.