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Menactra: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Phase 3

Neisseria Meningitidis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jul 14, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Clinical trial landscape

Menactra: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine · 1 trial · 2 indications

Phase 3 1
NCT00444951Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi ArabiaNeisseria Meningitidis
COMPLETED450 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Neisseria Meningitidis
NCT00444951450
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Study Endpoints

Primary Endpoints

Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Baseline (Day 0) and Day 28 after vaccination

Secondary Endpoints

Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Baseline (Day 0) and Day 28 After Vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Day 0 to Day 7 Post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® groupEXPERIMENTALHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
Mencevax® groupEXPERIMENTALHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Control groupEXPERIMENTALParticipants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.

Interventions

NameTypeDescription
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineBIOLOGICAL0.5 mL, Intramuscular
Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccineBIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria

Age Range16 Years to 19 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Healthy, as determined by medical history and physical examination. * Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive). * For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at le...

Countries:Saudi Arabia
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