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Haemophilus influenzae type b

Phase 3

Haemophilus Influenzae Type b | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Feb 8, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment956

FDA Designations

No designations recorded

Clinical trial landscape

Haemophilus influenzae type b · 2 trials · 1 indication

Phase 3 1Phase 1 1
NCT00808392Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type bHaemophilus Influenzae Type b
COMPLETED916 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Haemophilus Influenzae Type b
NCT00808392916
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Study Endpoints

Primary Endpoints

Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
90 days
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.
30 days

Secondary Endpoints

Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.
90 days
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.
90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Haemophilus influenzae type b vaccineBIOLOGICAL3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
Commercial Haemophilus influenzae type b vaccineBIOLOGICAL3 doses one month apart of Haemophilus influenzae type b vaccine.
Haemophilus influenzae type bBIOLOGICAL1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months
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Eligibility Criteria

Age Range2 Months to 4 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Infants of either sex, aged 2 - 4 months * In good health as determined by: * medical history * physical examination * clinical judgment of the investigator; * Available for all visits scheduled in the study and able to comply with all study regulations * For whom writt...

Countries:China
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Frequently asked questions about Haemophilus influenzae type b

What is Haemophilus influenzae type b used for?

Haemophilus influenzae type b (Hib) is a vaccine developed by Novartis AG for the prevention of Haemophilus influenzae type b infections, including invasive Hib disease. It is indicated for use in infants and children to protect against infections caused by the Hib bacterium, such as meningitis and pneumonia.

Who makes Haemophilus influenzae type b?

Haemophilus influenzae type b is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is being investigated for the prevention of Haemophilus influenzae type b infections in pediatric populations.

What phase is Haemophilus influenzae type b in?

Haemophilus influenzae type b is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 1 trial, with no active trials currently ongoing. The vaccine is investigational and has not been approved for use in any market.

What clinical trials is Haemophilus influenzae type b in?

Haemophilus influenzae type b has completed three clinical trials: NCT00734565 (Phase 1, safety and reactogenicity), NCT00808392 (Phase 3, safety and immunogenicity), and NCT01044316 (Phase 3, comparing two doses of the vaccine). A fourth trial, NCT01226953, evaluated a booster dose in infants. All trials were conducted in China.

How does Haemophilus influenzae type b work?

Haemophilus influenzae type b is a monovalent conjugated vaccine that works by stimulating the immune system to produce antibodies against the Haemophilus influenzae type b bacterium. The vaccine is conjugated to a carrier protein, either diphtheria toxin CRM197 or tetanus toxoid, to enhance the immune response in infants.

Is Haemophilus influenzae type b the same as a Hib vaccine?

Yes, Haemophilus influenzae type b is commonly referred to as a Hib vaccine. It is designed to prevent infections caused by the Haemophilus influenzae type b bacterium, including invasive diseases such as meningitis and epiglottitis. The vaccine is being studied in pediatric populations in China.