Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Menitorix · 1 trial · 2 indications
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.
rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
| Arm | Type | Description |
|---|---|---|
| Preterm group | EXPERIMENTAL | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. |
| Full-term group | ACTIVE_COMPARATOR | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. |
| Name | Type | Description |
|---|---|---|
| Menitorix™ | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study. |
| Infanrix™ penta | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study |
| Prevenar™ | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study. |
| Infanrix™ IPV | BIOLOGICAL | Intramuscular injection, 1 dose in the Booster study. |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 8 and 12 weeks of age at the time of the ...
Menitorix is an investigational monoclonal antibody being developed for Haemophilus Influenzae Type b, a bacterial infection. It is studied in the context of infectious disease, specifically for use in preterm infants. The drug is currently in Phase 3 clinical development and is not yet approved.
Menitorix targets Haemophilus Influenzae Type b and Neisseria Meningitidis, as indicated in its clinical trial. It is a monoclonal antibody designed to address these bacterial pathogens. The drug is being evaluated for its immunogenicity and safety in preterm infants.
Menitorix is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in the target population.
Menitorix is in Phase 3 clinical development. It has completed one Phase 3 trial, and it remains investigational, meaning it is not yet approved by regulatory authorities. The drug is being studied for its potential use in preventing Haemophilus Influenzae Type b infection.
Menitorix has one completed Phase 3 clinical trial, identified as NCT00586612. This study evaluated the immunogenicity and safety of the Menitorix vaccine in preterm infants, enrolling 313 participants in Spain. The trial was active-controlled and included healthy volunteers.
Menitorix is being studied for its effects on both Haemophilus Influenzae Type b and Neisseria Meningitidis, which can cause meningitis. The clinical trial NCT00586612 includes these conditions, indicating the drug's potential role in preventing meningitis caused by these bacteria.