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Vaxem Hib

Phase 3

Haemophilus Influenzae Type b (Hib) Infection | Vaccine | Infectious Disease |Novartis AG|Trials Updated: Dec 8, 2011

Vaxem Hib target and mechanism

ModalityVaccine

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

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

Vaxem Hib clinical trials

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) InfectionUnlock trial analytics

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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Frequently asked questions about Vaxem Hib

What is Vaxem Hib used for?

Vaxem Hib is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. Hib is a bacterial infection that can cause serious illness, particularly in young children. The vaccine is intended for immunization against Hib disease, including use as a booster dose in toddlers.

Who makes Vaxem Hib?

Vaxem Hib is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the vaccine's development and clinical evaluation.

What phase is Vaxem Hib in?

Vaxem Hib has been evaluated in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and is not described as approved.

What clinical trials is Vaxem Hib in?

Vaxem Hib has been studied in a completed Phase 3 trial, NCT01025544, titled a study in toddlers aged 12 to 18 months comparing a booster dose of Vaxem Hib and Hiberix vaccines for the prevention of Haemophilus influenzae type b infections in China. The trial enrolled 846 healthy volunteers.

Is Vaxem Hib the same as Hiberix?

No, Vaxem Hib and Hiberix are different vaccines. They were compared head to head as booster doses in a Phase 3 trial in China. Vaxem Hib is also known as Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine).