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Hib-CRM197 · 1 trial · 1 indication
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37\_07E1 trial.
| Arm | Type | Description |
|---|---|---|
| Hib CRM197 | EXPERIMENTAL | Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial |
| Hib TT | ACTIVE_COMPARATOR | Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial |
| Name | Type | Description |
|---|---|---|
| Hib-CRM197 | BIOLOGICAL | No vaccine administered in V37\_07E2 study |
| Hib-TT | BIOLOGICAL | No vaccine administered in V37\_07E2 study |
Inclusion Criteria: 1. Children previously enrolled in V37\_07E1 study and who received the appropriate vaccination. 2. Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements. Exclusion Criteria...
Hib-CRM197 is an investigational vaccine being studied for the prevention of meningitis, epiglottitis, pneumonia, and arthritis caused by Haemophilus influenzae type b. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Hib-CRM197 is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing invasive Haemophilus influenzae type b disease.
Hib-CRM197 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA or other regulatory agencies. One Phase 3 trial has been completed, and the vaccine remains under investigation.
Hib-CRM197 has been studied in one completed Phase 3 trial, NCT02139228, which evaluated the persistence of immunity after vaccination with Hib-CRM197 or a Hib-TT vaccine in Chinese children. The trial enrolled 426 participants and was conducted in China.
No, Hib-CRM197 is not the same as Hib-TT. They are different vaccines against Haemophilus influenzae type b, each using a distinct carrier protein. The clinical trial NCT02139228 compared the persistence of immunity between the two vaccines.