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Measles, Mumps, Rubella and Varicella

Phase 3

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,664

FDA Designations

No designations recorded

Clinical trial landscape

Measles, Mumps, Rubella and Varicella · 1 trial · 5 indications

Phase 3 1
NCT00422292Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy ToddlersMeningococcal Meningitis
COMPLETED1,664 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
Meningococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)
Day 30 after the 12-month vaccination

Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.

Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4
Day 30 after the 12-month vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® at 9 and 12 MonthsEXPERIMENTALParticipants will received Menactra® vaccination at 9 and 12 months of age.
Menactra® at 9 Months and Menactra® + MMRV at 12 MonthsEXPERIMENTALParticipants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
Menactra® at 9 Months and Menactra® + PCV at 12 MonthsEXPERIMENTALParticipants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
MMRV + PCV at 12 MonthsACTIVE_COMPARATORParticipants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age

Interventions

NameTypeDescription
Meningococcal Polysaccharide Diphtheria Conjugate VaccineBIOLOGICAL0.5 mL dose, intramuscular (IM)
Measles, Mumps, Rubella and VaricellaBIOLOGICAL0.5 mL dose, SC
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Eligibility Criteria

Age Range9 Months to 12 Months
SexALL
Healthy VolunteersYes
Study Sites88

Inclusion Criteria : * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment * The parent or legal guardian has signed and dated the Institutional Review B...

Countries:United StatesPuerto Rico
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Frequently asked questions about Measles, Mumps, Rubella and Varicella

What is Measles, Mumps, Rubella and Varicella used for?

Measles, Mumps, Rubella and Varicella is a vaccine being studied for use in healthy volunteers and for meningococcal meningitis. It is a combination vaccine that includes components for measles, mumps, rubella, and varicella, and is being evaluated in clinical trials for its immunogenicity and safety.

Who makes Measles, Mumps, Rubella and Varicella?

Sanofi (ticker: SNY) is the developer of Measles, Mumps, Rubella and Varicella. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.

What phase is Measles, Mumps, Rubella and Varicella in?

Measles, Mumps, Rubella and Varicella is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trials are completed, with one trial enrolling 1,664 participants and another enrolling 525 participants.

What clinical trials is Measles, Mumps, Rubella and Varicella in?

Measles, Mumps, Rubella and Varicella has been studied in two Phase 3 trials. NCT00422292 evaluated the vaccine's immunogenicity and safety when administered with Menactra in healthy toddlers in the United States and Puerto Rico. NCT03630705 assessed a quadrivalent meningococcal conjugate vaccine given with routine pediatric vaccines in healthy infants and toddlers in Russia and Mexico.

Is Measles, Mumps, Rubella and Varicella the same as Measles, combinations with mumps and rubella, live attenuated?

Yes, Measles, Mumps, Rubella and Varicella is also known as Measles, combinations with mumps and rubella, live attenuated. This alternative name reflects the vaccine's composition, which includes live attenuated components for measles, mumps, and rubella, along with varicella.