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Menomune: A, C, Y, W 135 Meningococcal Polysaccharide

Phase 2

Meningitis | Biologics | Infectious Disease |Sanofi|Trials Updated: Sep 20, 2013

Menomune: A, C, Y, W 135 Meningococcal Polysaccharide development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2009

Menomune: A, C, Y, W 135 Meningococcal Polysaccharide target and mechanism

ModalityBiologics

Also known as Menomune®

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment355

FDA Designations

No designations recorded

Menomune: A, C, Y, W 135 Meningococcal Polysaccharide clinical trials

Menomune: A, C, Y, W 135 Meningococcal Polysaccharide · 2 trials · 3 indications

Phase 2 1Phase 1/2 1
NCT01239043Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial VaccinationMeningitis
COMPLETED139 Analytics
PHASE2COMPLETED
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Day 0 to Day 7 post-vaccination

Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
0-7 days post-vaccination 1

Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
0-7 Days Post-vaccination 2

Solicited injection site reactions: Pain, Erythema, and Swelling.

Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Day 0 to 7 Post-vaccination 2

Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menomune® vaccine groupEXPERIMENTALParticipants received Menomune® vaccine in MTA29 (NCT00874549)
Menactra® vaccine groupEXPERIMENTALParticipants received Menactra® vaccine in trial MTA29 (NCT00874549)
Group 1: Menomune Day 0ACTIVE_COMPARATORParticipants received a single dose of Menomune® vaccine on Day 0.
Group 2: Menactra® Day 0 x 2EXPERIMENTALParticipants received two single-dose injections of Menactra® vaccine on Day 0
Group 3: Menactra® Day 0 and 14EXPERIMENTALParticipants received a single dose of Menactra® vaccine on Day 0 and on Day 14
Group 4: Menactra® Day 0 and 28EXPERIMENTALParticipants received a single dose of Menactra® vaccine on Day 0 and on Day 28.

Interventions

NameTypeDescription
Menomune®: A, C, Y, W 135 Meningococcal PolysaccharideBIOLOGICAL0.5 mL, Subcutaneous
Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, Intramuscular
Menomune®: A, C, Y, W-135 Meningococcal PolysaccharideBIOLOGICAL0.5 mL, Subcutaneous
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range56 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Aged 56 years or older on the day of inclusion. * Received the appropriate Menactra or Menomune vaccine as assigned by randomization in Trial MTA29. * Ambulatory and healthy, as determined by medical history. * Informed consent form has been signed and dated. * Able to attend ...

Countries:United States
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Frequently asked questions about Menomune: A, C, Y, W 135 Meningococcal Polysaccharide

What is Menomune: A, C, Y, W-135 Meningococcal Polysaccharide?

Menomune: A, C, Y, W-135 Meningococcal Polysaccharide is a biologic vaccine developed by Sanofi for meningitis and meningococcal infections. It is a polysaccharide vaccine covering serogroups A, C, Y, and W-135, and it has been studied in older adults, including healthy volunteers aged 56 years and above.

What is Menomune: A, C, Y, W-135 Meningococcal Polysaccharide used for?

Menomune: A, C, Y, W-135 Meningococcal Polysaccharide is used for the prevention of meningitis and meningococcal infections. Its clinical studies enrolled healthy volunteers aged 56 years and older in the United States, evaluating safety and immune response against meningococcal disease in that age group.

Who makes Menomune: A, C, Y, W-135 Meningococcal Polysaccharide?

Menomune: A, C, Y, W-135 Meningococcal Polysaccharide is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer associated with the vaccine, and the clinical trials of Menomune were sponsored and conducted under the Sanofi organization.

What phase is Menomune: A, C, Y, W-135 Meningococcal Polysaccharide in?

Menomune: A, C, Y, W-135 Meningococcal Polysaccharide is in Phase 2 development. Its recorded clinical program includes one completed Phase 2 trial and one completed Phase 1/Phase 2 trial, and no trials are currently active. The vaccine remains an investigational asset in Sanofi's clinical development record.

What clinical trials is Menomune: A, C, Y, W-135 Meningococcal Polysaccharide in?

Menomune: A, C, Y, W-135 Meningococcal Polysaccharide has been studied in two completed trials: NCT01239043, a Phase 2 trial of antibody persistence and response to revaccination with Menactra or Menomune three years after initial vaccination, and NCT00874549, a Phase 1/Phase 2 safety and immunogenicity trial in subjects aged 56 years and older.

Is Menomune: A, C, Y, W-135 Meningococcal Polysaccharide the same as Menomune?

Yes. Menomune: A, C, Y, W-135 Meningococcal Polysaccharide is the same product referred to as Menomune, including the variants Menomune: A, C, Y, W 135 Meningococcal Polysaccharide and Menomune: A, C, Y, W-135 Meningococcal Polysaccharide. These names all refer to the same Sanofi meningococcal polysaccharide vaccine.