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Haemophilus Influenzae Type b vaccine

Phase 2

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

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

Haemophilus Influenzae Type b vaccine · 1 trial · 2 indications

Phase 2 1
NCT00771849Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in ChildrenMeningitis
COMPLETED103 Analytics
PHASE2COMPLETED
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Day 0 (before) and 28 days post-vaccination

Secondary Endpoints

Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
28 days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® Vaccine GroupEXPERIMENTALParticipants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
Hiberix® Vaccine GroupACTIVE_COMPARATORParticipants receiving Haemophilus Influenzae Type b (Hib) vaccine

Interventions

NameTypeDescription
Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, Intramuscular
Haemophilus Influenzae Type b (Hib) vaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range2 Years to 4 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Participant is healthy, as determined by medical history and physical examination. * Participant is 2 years to \< 5 years of age at the time of vaccination. * At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed. * Parent/...

Countries:United Kingdom
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Frequently asked questions about Haemophilus Influenzae Type b vaccine

What is Haemophilus Influenzae Type b vaccine used for?

Haemophilus Influenzae Type b vaccine is being studied for use in meningitis, a serious infection of the membranes covering the brain and spinal cord. It is an investigational vaccine developed by Sanofi, currently in Phase 2 clinical development for this indication.

Who makes Haemophilus Influenzae Type b vaccine?

Sanofi (ticker: SNY) is developing Haemophilus Influenzae Type b vaccine. The vaccine is currently in Phase 2 clinical trials for meningitis, and it is an investigational product, meaning it has not yet been approved for use.

What phase is Haemophilus Influenzae Type b vaccine in?

Haemophilus Influenzae Type b vaccine is in Phase 2 clinical development. It is an investigational vaccine, not yet approved, and is being studied for the prevention of meningitis. One Phase 2 trial has been completed.

What clinical trials is Haemophilus Influenzae Type b vaccine in?

Haemophilus Influenzae Type b vaccine has one completed Phase 2 trial, NCT00771849, titled 'Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children.' The trial enrolled 103 participants in the United Kingdom, studying meningitis and meningococcemia.

Is Haemophilus Influenzae Type b vaccine a monoclonal antibody?

Yes, Haemophilus Influenzae Type b vaccine is classified as a monoclonal antibody modality. It is being developed by Sanofi for meningitis and is currently in Phase 2 clinical trials, with one completed study involving 103 participants.