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Also known as Meningococcal C Conjugate Vaccine, Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Menjugate · 2 trials · 2 indications
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
The cut-off value for rSBA-MenC titers was ≥ 1:8.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Menjugate Group | EXPERIMENTAL | Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Menjugate vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Nimenrix 3 Group | EXPERIMENTAL | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age. |
| Nimenrix 2 Group | EXPERIMENTAL | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| NeisVac-C Group | ACTIVE_COMPARATOR | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| Name | Type | Description |
|---|---|---|
| Nimenrix (GSK134612 vaccine) | BIOLOGICAL | Intramuscular, 1 dose |
| Menjugate | BIOLOGICAL | Intramuscular, 1 dose |
| Nimenrix™ | BIOLOGICAL | 4- or 3-dose intramuscular injection |
| Menjugate® | BIOLOGICAL | 3-dose intramuscular injection |
| NeisVac-CTM | BIOLOGICAL | 3-dose intramuscular injection |
| Infanrix™ hexa | BIOLOGICAL | 4-dose intramuscular injection |
| Synflorix™ | BIOLOGICAL | 4-dose intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination...
Menjugate is a meningococcal vaccine developed for the prevention of meningococcal infections. It is studied in healthy children and infants, including co-administration with pneumococcal and DTPa-HBV-IPV/Hib vaccines. Its clinical program covers infections and meningococcal disease in the infectious disease therapeutic area.
Menjugate is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating the vaccine, including the Phase 3 studies NCT01266993 and NCT01144663.
Menjugate is in Phase 3 clinical development. Two Phase 3 trials have been completed, with no trials currently active. The program has enrolled a total of 2,366 participants across randomized, controlled studies.
Menjugate has been evaluated in two completed Phase 3 trials. NCT01266993 was a persistence and booster study in healthy children aged 4 years and older in France and Germany, enrolling 271 participants. NCT01144663 assessed immunogenicity and safety when co-administered with pneumococcal and DTPa-HBV-IPV/Hib vaccines in Estonia, Germany, and Spain, enrolling 2,095 participants.
Yes. Menjugate, Menjugate™, and Menjugate® refer to the same GSK meningococcal vaccine. The trademark symbols are simply stylized forms of the same product name, so searches for any of these variants point to the identical asset.