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Meningococcal Group C Conjugate vaccine: MenC

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Aug 19, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Group C Conjugate vaccine: MenC · 1 trial · 2 indications

Phase 3 1
NCT01359449Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine ImmunizationsMeningitis
COMPLETED123 Analytics
PHASE3COMPLETED
Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination

Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination

Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination

Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination

Secondary Endpoints

Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
28 days post-vaccination
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
28 days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® Vaccine GroupEXPERIMENTALMeningococcal vaccine naive participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) at 12 months of age and at 18 months of age concomitantly with routine vaccines administered as per provincial schedule
Menjugate® Vaccine GroupACTIVE_COMPARATORMeningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.

Interventions

NameTypeDescription
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®BIOLOGICAL0.5 mL, Intramuscular
Meningococcal Group C Conjugate vaccine: MenCBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 12 months (365 to 400 days) on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally authorized representative * Subject and parent/legal repr...

Countries:Canada
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Frequently asked questions about Meningococcal Group C Conjugate vaccine: MenC

What is Meningococcal Group C Conjugate vaccine MenC used for?

Meningococcal Group C Conjugate vaccine MenC is used for meningitis, specifically to prevent meningococcal infection caused by group C bacteria. It is an investigational vaccine being developed for this infectious disease indication.

Who makes Meningococcal Group C Conjugate vaccine MenC?

Sanofi (ticker: SNY) is developing Meningococcal Group C Conjugate vaccine MenC. The vaccine is currently in Phase 3 clinical development for the prevention of meningitis and meningococcal infection.

What phase is Meningococcal Group C Conjugate vaccine MenC in?

Meningococcal Group C Conjugate vaccine MenC 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 Group C Conjugate vaccine MenC in?

Meningococcal Group C Conjugate vaccine MenC has one completed Phase 3 trial, NCT01359449, which studied two doses of Menactra or one dose of the monovalent vaccine with routine immunizations in 123 participants in Canada.

Is Meningococcal Group C Conjugate vaccine MenC the same as Menactra?

Meningococcal Group C Conjugate vaccine MenC is not the same as Menactra. The clinical trial NCT01359449 compared the monovalent MenC vaccine against Menactra, which is a different quadrivalent meningococcal vaccine used as an active control.