Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal C Conjugate Vaccine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1: 2+4 Months (2-doses) | EXPERIMENTAL | - |
| Group 2: 2 Months (1-dose) | EXPERIMENTAL | - |
| Group 3: 6 Months (1-dose) | EXPERIMENTAL | - |
| Group 4: 12-16 Months (1 dose in the second year of life) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Meningococcal C conjugate vaccine | BIOLOGICAL | Meningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age |
Inclusion Criteria: * healthy infants Exclusion Criteria: * known hypersensitivity to any vaccine component * significant acute or chronic infections * previously ascertained or suspected disease caused by N. meningitidis * previous household contact with an individual with a positive culture of ...
Meningococcal C Conjugate Vaccine is used for the prevention of meningococcal infection. It is a vaccine developed by Novartis AG and is designed to protect against disease caused by Neisseria meningitidis serogroup C. Clinical studies have evaluated it in healthy children, including premature and non-premature infants.
Meningococcal C Conjugate Vaccine is developed by Novartis AG, which trades under the ticker NVS. The vaccine was studied in Phase 3 clinical trials sponsored by the company, including trials conducted in Germany, Poland, and Italy in healthy pediatric populations.
Meningococcal C Conjugate Vaccine has been studied in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The vaccine is an investigational product in the clinical development setting described by these studies.
Two completed Phase 3 trials evaluated Meningococcal C Conjugate Vaccine. NCT00311415 studied immunogenicity, safety, tolerability, and ability to prime for memory in 257 healthy children in Germany and Poland. NCT00310674 studied immunogenicity, safety, and tolerability in 150 healthy premature and non-premature children in Italy.
Both Phase 3 trials of Meningococcal C Conjugate Vaccine were randomized and active-controlled, enrolling a total of 407 healthy children. NCT00311415 enrolled children from 7 weeks of age, and NCT00310674 enrolled children from 11 weeks of age, including premature infants. Both trials have been completed.