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MenitorixTM · 1 trial · 2 indications
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
| Arm | Type | Description |
|---|---|---|
| Synflorix-Meningitec Group | EXPERIMENTAL | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. |
| Synflorix-NeisVac-C Group | EXPERIMENTAL | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. |
| Synflorix-Menitorix Group | EXPERIMENTAL | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. |
| Prevenar-Menitorix Group | ACTIVE_COMPARATOR | Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. |
| Name | Type | Description |
|---|---|---|
| MenitorixTM | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. |
| Pneumococcal conjugate vaccine GSK1024850A | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. |
| PrevenarTM | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study. |
| MeningitecTM | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study |
| NeisVac-CTM | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study |
| InfanrixTM hexa | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study |
| InfanrixTM penta | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study |
| InfanrixTM IPV/Hib | BIOLOGICAL | Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study |
| InfanrixTM IPV | BIOLOGICAL | Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 ...
Menitorix is a vaccine being developed for Neisseria meningitidis, the bacterium that causes meningococcal disease. It is also studied for Haemophilus influenzae type b. The drug is in Phase 3 clinical development and is being investigated in children as young as 36 months.
Menitorix is 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 ability to produce persistent antibodies against meningococcal and Hib infections.
Menitorix is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. A completed Phase 3 trial has evaluated its effects, but the drug remains under study and is not yet available commercially.
Menitorix has one completed Phase 3 trial registered as NCT00891176, titled 'Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines.' The trial enrolled 582 participants in Germany, Poland, and Spain, and was an active-controlled, randomized study.
Menitorix is a monoclonal antibody designed to target Neisseria meningitidis. By binding to the bacteria, it helps the immune system recognize and fight the infection. The vaccine is being studied to assess its ability to generate lasting antibody responses against meningococcal disease.