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Meningococcal Group C-CRM197 Conjugate Vaccine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment285
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06165276A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center StudyPHASE1 COMPLETED 285 — — Jul 25, 2006Aug 27, 2008Dec 11, 2023 - —
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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 — 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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