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V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B, & Haemophilus influenza type b conjugate vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment151

FDA Designations

No designations recorded

Clinical trial landscape

V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B, & Haemophilus influenza type b conjugate vaccine · 1 trial · 5 indications

Phase 3 1
NCT00092469Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)Diphtheria
COMPLETED151 Analytics
PHASE3COMPLETED
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
Diphtheria
NCT00092469151
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Study Endpoints

Primary Endpoints

Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range6 Weeks to 8 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen Exclusion Criteria: * Problems with immune system * Recent illness with fever

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