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Haemophilus b Conjugate Vaccine

Phase 3

Healthy Volunteers (Meningococcal Infection) | Monoclonal antibody | Other |Sanofi|Last Updated: Jun 25, 2024

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment950
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03691610Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and ToddlersPHASE3 COMPLETED 950 — — Oct 4, 2018Oct 20, 2023Jun 25, 202447 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase from baseline for participant with pre-vaccination hSBA titer \>= 1:8.

Secondary Endpoints
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALMenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2ACTIVE_COMPARATORMENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 3EXPERIMENTALMenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4ACTIVE_COMPARATORMenactra® at 17 to 19 months of age and 20 to 23 months of age
Interventions
NameTypeDescription
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccineBIOLOGICALPharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineBIOLOGICALPharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate VaccineBIOLOGICALPharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate VaccineBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus VaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Haemophilus b Conjugate VaccineBIOLOGICALPharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pneumococcal 13-valent Conjugate VaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Rotavirus Vaccine, Live, Oral, PentavalentBIOLOGICALPharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Hepatitis B VaccineBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Measles, Mumps, and Rubella Virus Vaccine LiveBIOLOGICALPharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Varicella Virus Vaccine LiveBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
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Eligibility Criteria
Age Range6 Months — 19 Months
SexALL
Healthy VolunteersYes
Study Sites47

Inclusion criteria : * Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit * Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations * Subject and parent/guardian are able to ...

Countries:United StatesPuerto Rico
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