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Inactivated Poliomyelitis vaccine

Phase 3

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

Inactivated Poliomyelitis vaccine development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Nov 2005

Inactivated Poliomyelitis vaccine target and mechanism

ModalityVaccine

Also known as Inactivated Poliomyelitis vaccine (IMOVAX), IMOVAX Polio™ (IPV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment276

FDA Designations

No designations recorded

Inactivated Poliomyelitis vaccine clinical trials

Inactivated Poliomyelitis vaccine · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00258843Safety of Imovax Polio in Chinese Infants and ChildrenPoliomyelitis
COMPLETED40 Analytics
PHASE3COMPLETED
Safety of Imovax Polio in Chinese Infants and Children
PoliomyelitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
1 Month Post-vaccination

Secondary Endpoints

Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines
1 Month post-vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALChildren at 18 months of age
Group 2EXPERIMENTALInfants at 2 months of age
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Inactivated Poliomyelitis vaccineBIOLOGICAL0.5 mL, intramuscular (IM)
Inactivated Poliomyelitis vaccine (IMOVAX)BIOLOGICALFractional dose (1/5th) 0.1 mL, intradermally
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Eligibility Criteria

Age Range2 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Group 1: Aged 18 months (18-20 months) on the day of inclusion * Group 2: Aged 2 months (56-70 days) on the day of inclusion Exclusion Criteria: * Participation in another clinical trial in the 4 weeks preceding the trial vaccination * Planned participation in another clinic...

Countries:ChinaPhilippines
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Frequently asked questions about Inactivated Poliomyelitis vaccine

What is Inactivated Poliomyelitis vaccine used for?

Inactivated Poliomyelitis vaccine is used to prevent poliomyelitis, a viral disease that can cause paralysis. It is given as a vaccine to healthy infants and children, and the clinical trials supporting it enrolled participants from 42 days of age. The product is marketed under the name IMOVAX.

Who makes Inactivated Poliomyelitis vaccine?

Sanofi develops and manufactures the Inactivated Poliomyelitis vaccine, which is marketed as IMOVAX. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is part of Sanofi's infectious disease portfolio.

What phase is Inactivated Poliomyelitis vaccine in?

The Inactivated Poliomyelitis vaccine is in Phase 3 clinical development. Two trials have been completed, including a Phase 3 safety study in Chinese infants and children and a Phase 2 immunogenicity study. No trials are currently active.

What clinical trials is Inactivated Poliomyelitis vaccine in?

Two completed trials studied the Inactivated Poliomyelitis vaccine. NCT00604058 was a Phase 2 trial in the Philippines comparing fractional intradermal doses with full intramuscular doses in 236 participants. NCT00258843 was a Phase 3 safety trial of IMOVAX in 40 Chinese infants and children.

Is Inactivated Poliomyelitis vaccine the same as IMOVAX?

Yes, IMOVAX is the brand name for Sanofi's Inactivated Poliomyelitis vaccine. The two names refer to the same vaccine product, and the Phase 3 trial NCT00258843 was conducted under the IMOVAX name in Chinese infants and children.

How is Inactivated Poliomyelitis vaccine studied in clinical trials?

Trials of the Inactivated Poliomyelitis vaccine have used active-controlled, randomized designs. NCT00604058 compared fractional intradermal doses against full intramuscular doses, while NCT00258843 evaluated safety in Chinese infants and children. Together the two completed studies enrolled 276 participants.