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Poliomyelitis Vaccine inactivated

Phase 3

Poliomyelitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 22, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Poliomyelitis Vaccine inactivated · 1 trial · 2 indications

Phase 3 1
NCT00348387Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPVPoliomyelitis
COMPLETED600 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
PoliomyelitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
1 month post-vaccination 3

Secondary Endpoints

To provide information concerning the safety of IMOVAX Polio™ vaccine
Entire study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Poliomyelitis Vaccine inactivatedBIOLOGICAL0.5 mL, Intramuscular
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)BIOLOGICAL1g dragee, oral
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Eligibility Criteria

Age Range60 Days to 70 Days
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 2 months (60-70 days) on the day of inclusion into the study * Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more * Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation...

Countries:China
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Frequently asked questions about Poliomyelitis Vaccine inactivated

What is Poliomyelitis Vaccine inactivated used for?

Poliomyelitis Vaccine inactivated is used for the prevention of poliomyelitis, a viral infection that can cause paralysis. It is an inactivated vaccine designed to protect against polio and is being studied for use in infants.

Who makes Poliomyelitis Vaccine inactivated?

Sanofi (ticker: SNY) is the developer of Poliomyelitis Vaccine inactivated. The vaccine is being investigated for the prevention of poliomyelitis.

What phase is Poliomyelitis Vaccine inactivated in?

Poliomyelitis Vaccine inactivated is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use. The Phase 3 trial has been completed.

What clinical trials is Poliomyelitis Vaccine inactivated in?

Poliomyelitis Vaccine inactivated has one completed Phase 3 trial, NCT00348387, which evaluated its immunogenicity and safety in Chinese infants compared to local oral polio vaccine. The trial enrolled 600 participants.

Is Poliomyelitis Vaccine inactivated the same as Imovax Polio?

Yes, Poliomyelitis Vaccine inactivated is the same as Imovax Polio. The Phase 3 trial NCT00348387 specifically studied Imovax Polio in Chinese infants.