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Meningococcal Group C-CRM197 Conjugate Vaccine

Phase 1

Meningococcal Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Dec 11, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment285

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Group C-CRM197 Conjugate Vaccine · 1 trial · 1 indication

Phase 1 1
NCT06165276A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center StudyMeningococcal Immunization
COMPLETED285 Analytics
PHASE1COMPLETED
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Meningococcal Immunization
NCT06165276285
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Study Endpoints

Primary Endpoints

Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Up to 7 days after injection
Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Up to 28 days after injection
Presence of serious adverse events (SAEs) throughout the trial.
From baseline up to 24 months
Incidence of treatment-emergent antibodies responses
From baseline up to 24 months

Secondary Endpoints

After booster dose of TetraMen-T: Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Up to 7 days after injection
After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Up to 28 days after injection
After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.
From baseline up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALAdults receiving Low Dose TetraMen-T with adjuvant
Group 2EXPERIMENTALAdults receiving High Dose TetraMen-T without adjuvant
Group 3EXPERIMENTALToddlers receiving Low Dose TetraMen-T with adjuvant
Group 4EXPERIMENTALToddlers receiving High Dose TetraMen-T without adjuvant
Group 5EXPERIMENTALInfants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months
Group 6EXPERIMENTALInfants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months
Group 7EXPERIMENTALInfants receiving High Dose TetraMen-T without adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months
Group 8ACTIVE_COMPARATORInfants receiving Menjugate ®. Subjects were to receive a booster dose of low-dose adjuvanted TetraMen-T at age 13 months. Routine vaccines were deferred.

Interventions

NameTypeDescription
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).BIOLOGICALPharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
Meningococcal Group C-CRM197 Conjugate VaccineBIOLOGICALPharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
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Eligibility Criteria

Age Range60 Days to 40 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: -Subject is healthy, as determined by medical history and physical assessment. -At the time of vaccination on Day 0, subject was the following age: Adults: aged ≥18 to \< 40 years Toddlers: aged ≥12 to \< 19 months Infants: aged 2 months + 28 days (60 to 88 days) * Institutiona...

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Frequently asked questions about Meningococcal Group C-CRM197 Conjugate Vaccine

What is Meningococcal Group C-CRM197 Conjugate Vaccine used for?

Meningococcal Group C-CRM197 Conjugate Vaccine is used for meningococcal immunization, which is vaccination against meningococcal disease caused by group C bacteria. It is being developed as a preventive vaccine for this infectious disease indication.

Who makes Meningococcal Group C-CRM197 Conjugate Vaccine?

Meningococcal Group C-CRM197 Conjugate Vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is Meningococcal Group C-CRM197 Conjugate Vaccine in?

Meningococcal Group C-CRM197 Conjugate Vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical testing to assess its safety and efficacy.

What clinical trials is Meningococcal Group C-CRM197 Conjugate Vaccine in?

Meningococcal Group C-CRM197 Conjugate Vaccine has one completed clinical trial registered under NCT06165276. This was a Phase 1, randomized, modified single-blind, active-controlled, four-stage, step-down, comparative, multi-center study that enrolled 285 participants, including healthy volunteers aged 60 days and older.

Is Meningococcal Group C-CRM197 Conjugate Vaccine the same as any other vaccine?

Meningococcal Group C-CRM197 Conjugate Vaccine is a conjugate vaccine that links group C meningococcal polysaccharide to the CRM197 carrier protein. This technology is used in several licensed meningococcal vaccines, but the specific formulation and manufacturing process may differ from other products.