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

Phase 3

Neisseria Meningitidis | Vaccine | 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 MeningitidisUnlock trial analytics

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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Frequently asked questions about Menactra: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

What is Menactra used for?

Menactra is a vaccine used to help prevent disease caused by Neisseria meningitidis, the bacteria that cause meningococcal infections. It is a meningococcal A, C, Y, and W 135 polysaccharide diphtheria toxoid conjugate vaccine, meaning it combines polysaccharides from four meningococcal serogroups with a diphtheria toxoid carrier protein.

Who makes Menactra?

Menactra is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer of the vaccine, which is designed to protect against Neisseria meningitidis, the bacterium responsible for meningococcal infections.

What phase is Menactra in?

Menactra has been studied in Phase 3 clinical development. One Phase 3 trial of the vaccine has been completed, and no trials are currently listed as active. The completed study was randomized, double blind, and controlled, and enrolled 450 participants.

What clinical trials is Menactra in?

Menactra has been evaluated in the Phase 3 trial NCT00444951, titled Immunogenicity and Safety of Menactra Vaccine in Adolescents in Saudi Arabia. That completed study enrolled 450 healthy volunteers aged 16 years and older of all sexes in Saudi Arabia and assessed immunogenicity and safety in adolescents.