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Measles-mumps-rubella-varicella vaccine

Phase 3

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 16, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment1,378

FDA Designations

No designations recorded

Clinical trial landscape

Measles-mumps-rubella-varicella vaccine · 1 trial · 5 indications

Phase 3 1
NCT00483574Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy ToddlersMeningococcal Meningitis
COMPLETED1,378 Analytics
PHASE3COMPLETED
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Meningococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Day 0 to 7 Post-vaccination

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: Menactra® and Routine Pediatric VaccinesEXPERIMENTALParticipants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 2: Routine Pediatric VaccinesOTHERParticipants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.

Interventions

NameTypeDescription
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, IM at age 9 and 12 months
Measles-mumps-rubella-varicella vaccineBIOLOGICAL0.5 mL, intramuscular at 12 months of age
Routine paediatric vaccine - Pneumococcal conjugate (PCV)BIOLOGICAL0.5 mL, Intramuscular at age 12 months
Routine paediatric vaccine - Hepatitis ABIOLOGICAL0.5 mL, Intramuscular at age 12 months
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Eligibility Criteria

Age Range9 Months to 12 Months
SexALL
Healthy VolunteersYes
Study Sites79

Inclusion Criteria : * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment * The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board...

Countries:United StatesChile
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Frequently asked questions about Measles-mumps-rubella-varicella vaccine

What is Measles-mumps-rubella-varicella vaccine used for?

Measles-mumps-rubella-varicella vaccine is used for meningococcal meningitis, as well as measles, mumps, rubella, and varicella. It is a monoclonal antibody being developed by Sanofi for infectious disease. The vaccine is currently in Phase 3 clinical development.

Who makes Measles-mumps-rubella-varicella vaccine?

Sanofi (ticker: SNY) is developing Measles-mumps-rubella-varicella vaccine. The vaccine is in Phase 3 clinical trials for meningococcal meningitis and other infectious diseases. Sanofi is conducting the development as part of its infectious disease portfolio.

What phase is Measles-mumps-rubella-varicella vaccine in?

Measles-mumps-rubella-varicella vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. The Phase 3 trial has been completed, with results from 1,378 participants.

What clinical trials is Measles-mumps-rubella-varicella vaccine in?

Measles-mumps-rubella-varicella vaccine is associated with clinical trial NCT00483574, titled 'Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers.' This Phase 3 trial was completed and enrolled 1,378 participants in the United States and Chile.

Is Measles-mumps-rubella-varicella vaccine the same as Menactra?

Measles-mumps-rubella-varicella vaccine is not the same as Menactra. The clinical trial NCT00483574 studied the safety of Menactra vaccine when administered with other pediatric vaccines, including measles-mumps-rubella-varicella vaccine. They are separate vaccines evaluated together in the trial.