Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Menactra®
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine · 1 trial · 5 indications
Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.
| Arm | Type | Description |
|---|---|---|
| Menactra® at 9 and 12 Months | EXPERIMENTAL | Participants will received Menactra® vaccination at 9 and 12 months of age. |
| Menactra® at 9 Months and Menactra® + MMRV at 12 Months | EXPERIMENTAL | Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age |
| Menactra® at 9 Months and Menactra® + PCV at 12 Months | EXPERIMENTAL | Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| MMRV + PCV at 12 Months | ACTIVE_COMPARATOR | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide Diphtheria Conjugate Vaccine | BIOLOGICAL | 0.5 mL dose, intramuscular (IM) |
| Measles, Mumps, Rubella and Varicella | BIOLOGICAL | 0.5 mL dose, SC |
Inclusion Criteria : * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment * The parent or legal guardian has signed and dated the Institutional Review B...
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine is used to prevent meningococcal meningitis, a serious bacterial infection of the membranes surrounding the brain and spinal cord. It is a vaccine developed by Sanofi. The clinical program also evaluated its use alongside pediatric vaccines against measles, mumps, rubella, and varicella in healthy toddlers.
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program studying this vaccine in pediatric populations.
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine has been studied in Phase 3 clinical development. The Phase 3 trial in the program is listed as completed, and no trials are currently active. It is an investigational vaccine candidate rather than a product with a stated approval in this program.
The program includes one completed Phase 3 trial, NCT00422292, titled Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra in Healthy Toddlers. It enrolled 1,664 participants aged 9 months and older in the United States and Puerto Rico, used an active-controlled design, and included healthy volunteers.
NCT00422292 was a Phase 3, randomized, active-controlled trial that enrolled 1,664 healthy toddlers from 9 months of age. Participants were recruited in the United States and Puerto Rico. The study evaluated immunogenicity and safety when pediatric vaccines were administered with the meningococcal vaccine, and it is now completed.