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Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b

Phase 3

Haemophilus Influenzae Type b (Hib) Infection | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment700

FDA Designations

No designations recorded

Clinical trial landscape

Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b · 1 trial · 1 indication

Phase 3 1
NCT01125527Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy ChildrenHaemophilus Influenzae Type b (Hib) Infection
COMPLETED700 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Haemophilus Influenzae Type b (Hib) Infection
NCT01125527700
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Study Endpoints

Primary Endpoints

Anti-PRP antibody levels at day 31 post last vaccination
30 days after last vaccination

Secondary Endpoints

Solicited local and systemic reactions, AEs, and SAEs
30 days post last vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)BIOLOGICALa single dose was administered
Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)BIOLOGICALa single dose was administered
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Eligibility Criteria

Age Range13 Months to 59 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Infants 13-59 months of age. Exclusion Criteria: * Prior Hib vaccine administration. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment. * Premature (before 37th week of gestati...

Countries:China
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