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Measles, Mumps, and Rubella Virus Vaccine Live

Phase 3

Healthy Volunteers (Meningococcal Infection) | Monoclonal antibody | Other |Sanofi|Last Updated: Oct 19, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment525

FDA Designations

No designations recorded

Clinical trial landscape

Measles, Mumps, and Rubella Virus Vaccine Live · 1 trial · 1 indication

Phase 3 1
NCT03630705Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and MexicoHealthy Volunteers (Meningococcal Infection)
COMPLETED525 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Healthy Volunteers (Meningococcal Infection)Unlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.

Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.

Secondary Endpoints

Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)
Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Day 0 (before the first vaccination with Hexacima® vaccine) of the infant series (i.e., at the age of 2 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: MenACYW Conjugate Vaccine (Mexico)EXPERIMENTALParticipants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)ACTIVE_COMPARATORParticipants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)EXPERIMENTALParticipants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)OTHERParticipants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.

Interventions

NameTypeDescription
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate VaccineBIOLOGICALPharmaceutical form: Liquid solution Route of administration : Intramuscular
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineBIOLOGICALPharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
Measles, Mumps, and Rubella Virus Vaccine LiveBIOLOGICALPharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
Pneumococcal 13-valent Conjugate VaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate VaccineBIOLOGICALPharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular
Hepatitis B VaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
Rotavirus Vaccine, Live, PentavalentBIOLOGICALPharmaceutical form: Oral solution Route of administration: Oral
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccineBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: Intramuscular
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Eligibility Criteria

Age Range2 Months to 12 Months
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: * Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.\* * Born after a full-term pregnancy, with an estimated gestation age \>= 37 weeks and a ...

Countries:MexicoRussia
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Frequently asked questions about Measles, Mumps, and Rubella Virus Vaccine Live

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.