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Meningococcal Diphtheria Toxoid Vaccine

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 19, 2022

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

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Clinical trial landscape

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 Meningococcal Diphtheria Toxoid Vaccine used for?

Meningococcal Diphtheria Toxoid Vaccine is used for the prevention of meningitis and meningococcal infection. It is an investigational vaccine being developed by Sanofi (SNY) and is currently in Phase 3 clinical development.

Who makes Meningococcal Diphtheria Toxoid Vaccine?

Sanofi (SNY) is developing Meningococcal Diphtheria Toxoid Vaccine. The vaccine is currently in Phase 3 clinical development for the prevention of meningitis and meningococcal infection.

What phase is Meningococcal Diphtheria Toxoid Vaccine in?

Meningococcal Diphtheria Toxoid Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Meningococcal Diphtheria Toxoid Vaccine in?

Meningococcal Diphtheria Toxoid Vaccine has one completed Phase 3 trial, NCT01890759, which evaluated immunogenicity and safety in subjects aged 9 to 23 months in India and the Russian Federation. The trial enrolled 300 participants and was uncontrolled.

Is Meningococcal Diphtheria Toxoid Vaccine the same as Menactra?

The completed clinical trial NCT01890759 evaluated the Menactra vaccine, which is a meningococcal diphtheria toxoid vaccine. This trial assessed the immunogenicity and safety of Menactra in subjects aged 9 to 23 months in India and Russia.