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Poliomyelitis Vaccine inactivated

Phase 3

Poliomyelitis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 22, 2014

Poliomyelitis Vaccine inactivated development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2006

Poliomyelitis Vaccine inactivated target and mechanism

ModalityVaccine

Also known as IMOVAX Polio ™

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

Poliomyelitis Vaccine inactivated clinical trials

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 to prevent poliomyelitis, commonly called polio, an infectious disease caused by poliovirus. It is an inactivated, injectable vaccine, meaning it contains killed virus rather than live virus. Sanofi develops this vaccine, which is studied in infants and other populations for protection against polio infection.

Who makes Poliomyelitis Vaccine inactivated?

Sanofi, which trades under the ticker SNY, is the developer of Poliomyelitis Vaccine inactivated. Sanofi is a global pharmaceutical company with an established vaccines business. The company conducted clinical development of this inactivated polio vaccine, including a Phase 3 study in Chinese infants.

What phase is Poliomyelitis Vaccine inactivated in?

Poliomyelitis Vaccine inactivated has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was an active-controlled, randomized Phase 3 trial that enrolled 600 participants. The vaccine is an investigational product in the context of this clinical program.

What clinical trials is Poliomyelitis Vaccine inactivated in?

Poliomyelitis Vaccine inactivated was evaluated in the Phase 3 trial NCT00348387, titled Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV. The trial enrolled 600 infants in China, was randomized and active-controlled, and has been completed. Participants were at least 60 days old, and the study included healthy volunteers.

Is Poliomyelitis Vaccine inactivated the same as Imovax Polio?

Yes, Imovax Polio is the brand name associated with Poliomyelitis Vaccine inactivated. The Phase 3 trial NCT00348387 refers to the product as Imovax Polio while comparing it to local oral polio vaccine in Chinese infants. Readers searching for Imovax Polio are looking at the same inactivated polio vaccine developed by Sanofi.

How does Poliomyelitis Vaccine inactivated work?

Poliomyelitis Vaccine inactivated works as a vaccine against poliomyelitis. It is an inactivated vaccine, meaning it uses killed poliovirus to stimulate an immune response without causing polio disease. The Phase 3 trial NCT00348387 assessed immunogenicity and safety in Chinese infants, comparing the inactivated vaccine with local oral polio vaccine.