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Meningococcal Diphtheria Toxoid Vaccine

Phase 3

Meningitis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Apr 19, 2022

Meningococcal Diphtheria Toxoid Vaccine development status

Highest phase Phase 3
Registered trials 4 across 2 sponsors since Apr 2007

Meningococcal Diphtheria Toxoid Vaccine target and mechanism

ModalityVaccine

Also known as Menactra®

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Meningococcal Diphtheria Toxoid Vaccine clinical trials

Meningococcal Diphtheria Toxoid Vaccine · 1 trial · 2 indications

Phase 3 1
NCT01890759Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian FederationMeningitis
COMPLETED300 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Day 0 (pre-vaccination) and Day 28 post-second vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.

Secondary Endpoints

Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Day 0 (pre-vaccination) and Day 28 post-vaccination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Meningococcal Diphtheria Toxoid VaccineEXPERIMENTALParticipants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart

Interventions

NameTypeDescription
Meningococcal Diphtheria Toxoid VaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range9 Months to 17 Months
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Male and female subjects aged 9 to 17 months on the day of inclusion * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) * Subject and parent/legally acceptable representative (if applicable) able to ...

Countries:IndiaRussia
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Frequently asked questions about Meningococcal Diphtheria Toxoid Vaccine

What is the Meningococcal Diphtheria Toxoid Vaccine used for?

The Meningococcal Diphtheria Toxoid Vaccine is used to prevent meningococcal infection and meningitis. It is a vaccine developed by Sanofi that stimulates an immune response against meningococcal disease. The vaccine is intended for use in young children, with clinical testing conducted in subjects aged 9 to 23 months.

Who makes the Meningococcal Diphtheria Toxoid Vaccine?

The Meningococcal Diphtheria Toxoid Vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi conducted the clinical development of this vaccine candidate for the prevention of meningococcal infection and meningitis.

What phase is the Meningococcal Diphtheria Toxoid Vaccine in?

The Meningococcal Diphtheria Toxoid Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed. The vaccine is investigational and has not been approved by the FDA based on the available information.

What clinical trials is the Meningococcal Diphtheria Toxoid Vaccine in?

The Meningococcal Diphtheria Toxoid Vaccine has been evaluated in one Phase 3 clinical trial, NCT01890759, titled Immunogenicity and Safety of Menactra Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation. The trial enrolled 300 participants, was conducted in India and Russia, and has been completed.

What does the Meningococcal Diphtheria Toxoid Vaccine target?

The Meningococcal Diphtheria Toxoid Vaccine targets meningococcal bacteria to prevent meningitis and meningococcal infection. It is a vaccine that uses diphtheria toxoid as a carrier protein to elicit an immune response against meningococcal disease.