Recent Updates
Recently added Catalysts

Menactra: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 16, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment238

FDA Designations

No designations recorded

Clinical trial landscape

Menactra: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate · 2 trials · 7 indications

Phase 3 2
NCT00539032Immunology and Safety of Menactra® in Children in Saudi ArabiaMeningitis
COMPLETED238 Analytics
NCT00483574Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy ToddlersMeningococcal Meningitis
COMPLETED1,378 Analytics
PHASE3COMPLETED
Immunology and Safety of Menactra® in Children in Saudi Arabia
Meningitis
NCT00539032238
Unlock trial analytics
PHASE3COMPLETED
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Meningococcal Meningitis
NCT004835741,378
Unlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Day 28 Post-vaccination
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Day 0 to 7 Post-vaccination

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: Menactra® Booster GroupEXPERIMENTALParticipants 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) GroupEXPERIMENTALParticipants 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 VaccinesEXPERIMENTALParticipants 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 VaccinesOTHERParticipants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.

Interventions

NameTypeDescription
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, Intramuscular
Measles-mumps-rubella-varicella vaccineBIOLOGICAL0.5 mL, intramuscular at 12 months of age
Routine paediatric vaccine - Pneumococcal conjugate (PCV)BIOLOGICAL0.5 mL, Intramuscular at age 12 months
Routine paediatric vaccine - Hepatitis ABIOLOGICAL0.5 mL, Intramuscular at age 12 months
Unlock Study Design Details

Eligibility Criteria

Age Range5 Years to 8 Years
SexALL
Healthy VolunteersYes
Study Sites4

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...

Countries:Saudi ArabiaUnited StatesChile
Unlock Eligibility Criteria