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Menactra: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate · 2 trials · 7 indications
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
| Arm | Type | Description |
|---|---|---|
| Group 1: Menactra® Booster Group | EXPERIMENTAL | Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine. |
| Group 2: Menactra® Primary Vaccine (Control) Group | EXPERIMENTAL | Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine. |
| Group 1: Menactra® and Routine Pediatric Vaccines | EXPERIMENTAL | Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months. |
| Group 2: Routine Pediatric Vaccines | OTHER | Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months. |
| Name | Type | Description |
|---|---|---|
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | BIOLOGICAL | 0.5 mL, Intramuscular |
| Measles-mumps-rubella-varicella vaccine | BIOLOGICAL | 0.5 mL, intramuscular at 12 months of age |
| Routine paediatric vaccine - Pneumococcal conjugate (PCV) | BIOLOGICAL | 0.5 mL, Intramuscular at age 12 months |
| Routine paediatric vaccine - Hepatitis A | BIOLOGICAL | 0.5 mL, Intramuscular at age 12 months |
Inclusion Criteria : * Healthy, as determined by medical history and physical examination. * Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive). * For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal polysacchar...
Menactra is a vaccine used to help prevent meningococcal disease, including meningitis and meningococcemia, caused by Neisseria meningitidis serogroups A, C, Y and W 135. It is given to healthy children and other individuals to stimulate immune protection against these bacterial infections.
Menactra is developed and manufactured by Sanofi, which trades under the ticker SNY. Sanofi produces the vaccine as a meningococcal polysaccharide diphtheria toxoid conjugate, meaning the polysaccharide antigens are linked to a diphtheria toxoid carrier protein.
Menactra has been studied in Phase 3 clinical development. The program includes completed Phase 3 trials, and no trials are currently listed as active. The studies enrolled healthy volunteers, including children and toddlers, to evaluate immunology and safety.
Menactra has been evaluated in completed Phase 3 trials including NCT00539032, which assessed immunology and safety in children in Saudi Arabia, and NCT00483574, which studied safety when given with other pediatric vaccines to healthy toddlers in the United States and Chile.
Menactra is a conjugate vaccine that combines meningococcal polysaccharides from serogroups A, C, Y and W 135 with a diphtheria toxoid carrier protein. This conjugate design is intended to generate an immune response against the bacteria that cause meningococcal meningitis and meningococcemia.