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Vaxem Hib

Phase 3

Haemophilus Influenzae Type b (Hib) Infection | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 8, 2011

Target and mechanism

ModalityMonoclonal antibody

Also known as Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment846

FDA Designations

No designations recorded

Clinical trial landscape

Vaxem Hib · 1 trial · 1 indication

Phase 3 1
NCT01025544Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in ChinaHaemophilus Influenzae Type b (Hib) Infection
COMPLETED846 Analytics
PHASE3COMPLETED
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Haemophilus Influenzae Type b (Hib) Infection
NCT01025544846
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)BIOLOGICALComparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Hiberix (Haemophilus influenzae type b (Hib) vaccine)BIOLOGICALComparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Toddlers 12-18 months of age who have previously participated in study M37P2. Exclusion Criteria: * Prior Hib booster administration. * History of serious reaction(s) following vaccination. * Vaccination within 14 days of study vaccination. * Known or suspected immune impair...

Countries:China
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