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DTwP-HepB-Hib Vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: May 19, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

DTwP-HepB-Hib Vaccine · 1 trial · 5 indications

Phase 3 1
NCT01470287Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of AgeDiphtheria
COMPLETED175 Analytics
PHASE3COMPLETED
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
DiphtheriaUnlock trial analytics

Study Endpoints

Primary Endpoints

Seroprotection rate one month after the last dose of vaccine administration
One month after last vaccination

Secondary Endpoints

Seroprotection rate and GMCs one month after the last vaccine administration
One month after last vaccination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
DTwP-HepB-Hib VaccineBIOLOGICALOpen label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.
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Eligibility Criteria

Age Range42 Days to 64 Days
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Male and female subjects ≥ 42 days to ≤ 64 days of age. 2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements Exclusion Criteria: 1. Subjects whose parents or lega...

Countries:India
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Frequently asked questions about DTwP-HepB-Hib Vaccine

What is DTwP-HepB-Hib Vaccine used for?

DTwP-HepB-Hib Vaccine is a fully liquid pentavalent vaccine used for immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type B. It is being developed for use in infants as young as 6 to 8 weeks of age.

Who makes DTwP-HepB-Hib Vaccine?

DTwP-HepB-Hib Vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in Phase 3 clinical development for the prevention of diphtheria and other infectious diseases.

What phase is DTwP-HepB-Hib Vaccine in?

DTwP-HepB-Hib Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under clinical investigation.

What clinical trials is DTwP-HepB-Hib Vaccine in?

DTwP-HepB-Hib Vaccine has one completed Phase 3 trial, NCT01470287, which evaluated its immunogenicity, safety, and tolerability in infants 6 to 8 weeks of age. The trial enrolled 175 participants in India and was an uncontrolled, non-randomized study.

Is DTwP-HepB-Hib Vaccine the same as a pentavalent vaccine?

Yes, DTwP-HepB-Hib Vaccine is a fully liquid pentavalent vaccine, meaning it combines five antigens in one formulation. It protects against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type B, offering broad coverage in a single injection.