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Infanrix Hexa · 1 trial · 1 indication
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
| Arm | Type | Description |
|---|---|---|
| rMenB Lot1 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| rMenB Lot2 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| rMenB Lot3 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| Routine | ACTIVE_COMPARATOR | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
| MenC + Routine | ACTIVE_COMPARATOR | Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) | BIOLOGICAL | One dose of rMenB Lot concomitantly with the routinely administered infant vaccines |
| Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) | BIOLOGICAL | One dose of rMenB concomitantly with the routinely administered infant vaccines |
| Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) | BIOLOGICAL | One dose of rMenB concomitantly with the routinely administered infant vaccines |
| Infanrix Hexa | BIOLOGICAL | Routine vaccination |
| Menjugate | BIOLOGICAL | One dose of the routinely administered infant vaccines + MenC vaccine |
| Prevenar | BIOLOGICAL | Routine vaccination |
Inclusion Criteria: * Healthy 2-month old infants (55-89 days, inclusive) Exclusion Criteria: * Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens) * Previous ascertained or suspected disease caused...
Infanrix Hexa is an investigational drug being studied for the prevention of Serogroup B Meningococcal Meningitis, a serious infectious disease. It is currently in Phase 3 clinical development. The drug has been evaluated in a clinical trial involving healthy infants to assess its immunogenicity and safety when given with routine infant vaccinations.
Infanrix Hexa is being developed by Novartis AG, a company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical development for the prevention of Serogroup B Meningococcal Meningitis. Novartis has conducted a Phase 3 clinical trial to evaluate the drug's safety and immunogenicity in healthy infants.
Infanrix Hexa is in Phase 3 clinical development. It is an investigational drug being studied for the prevention of Serogroup B Meningococcal Meningitis. The Phase 3 trial has been completed, and the drug is not yet approved for use. It remains under clinical investigation to assess its safety and efficacy.
Infanrix Hexa has been studied in one Phase 3 clinical trial with the identifier NCT00657709. This completed trial evaluated the immunogenicity, safety, and lot-to-lot consistency of the drug when administered with routine infant vaccinations to healthy infants. The trial enrolled 3,630 participants across Austria, Czechia, Finland, Germany, and Italy.
Infanrix Hexa is being developed for the prevention of Serogroup B Meningococcal Meningitis, a disease caused by Neisseria meningitidis serogroup B. The drug is currently in Phase 3 clinical development and has been studied in a clinical trial for its immunogenicity and safety in healthy infants. It is an investigational drug and not yet approved.