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 a vaccine developed for protection against Haemophilus influenzae type b and Neisseria meningitidis group C. It is studied in infants, including preterm infants, with the goal of preventing invasive disease caused by these bacteria. The Haemophilus influenzae type b indication is the primary focus of its clinical development program.
Menitorix is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor responsible for the clinical development of the vaccine, including the Phase 3 study conducted in preterm infants.
Menitorix is in Phase 3 clinical development. Its Phase 3 trial, NCT00586612, has been completed. The program includes one completed trial with no active trials currently listed, and the vaccine is investigational rather than approved.
Menitorix has been evaluated in the Phase 3 trial NCT00586612, titled a primary and booster study to evaluate the immunogenicity and safety of Menitorix vaccine in preterm infants. The trial enrolled 313 participants in Spain, included infants from 8 weeks of age, and has been completed.
Yes, Menitorix and Menitorix™ refer to the same vaccine. Menitorix™ is the trademarked form of the name used by GSK plc. Both names identify the same Haemophilus influenzae type b vaccine candidate in Phase 3 development.
The Phase 3 trial NCT00586612 was an active-controlled study evaluating the immunogenicity and safety of Menitorix in preterm infants. It enrolled 313 healthy volunteers in Spain, included both sexes, and had a minimum age of 8 weeks. The study was completed.