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Inactivated types 1, 2, and 3 poliovirus, D antigens

Phase 2

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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment225

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated types 1, 2, and 3 poliovirus, D antigens · 1 trial · 1 indication

Phase 2 1
NCT00885157Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose IntramuscularlyPoliomyelitis
COMPLETED225 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly
PoliomyelitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination.
30 days post-vaccination
Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine
30 days post-vaccination and entire study duration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALWill receive fractional doses of IPV Intradermally
Group BACTIVE_COMPARATORWill receive full doses of IPV Intramuscularly

Interventions

NameTypeDescription
Inactivated types 1, 2, and 3 poliovirus, D antigensBIOLOGICAL0.1 mL, intradermal
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Eligibility Criteria

Age Range15 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 15 to 18 months on the day of inclusion * Informed consent form signed by the parent(s) or other legally acceptable representative * Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures * Child having completed all visits o...

Countries:Philippines
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Frequently asked questions about Inactivated types 1, 2, and 3 poliovirus, D antigens

What is inactivated types 1, 2, and 3 poliovirus, D antigens used for?

Inactivated types 1, 2, and 3 poliovirus, D antigens is used for poliomyelitis, commonly called polio. It is the antigen component of an inactivated polio vaccine designed to stimulate immune protection against all three poliovirus types. Sanofi is the developer of this vaccine asset.

Who makes inactivated types 1, 2, and 3 poliovirus, D antigens?

Sanofi develops inactivated types 1, 2, and 3 poliovirus, D antigens. Sanofi trades under the ticker SNY. The asset is an inactivated polio vaccine antigen candidate studied for poliomyelitis prevention.

What phase is inactivated types 1, 2, and 3 poliovirus, D antigens in?

Inactivated types 1, 2, and 3 poliovirus, D antigens is in Phase 2 clinical development. It is investigational and has been studied in one completed Phase 2 trial. No active trials of this asset are currently listed.

What clinical trials is inactivated types 1, 2, and 3 poliovirus, D antigens in?

Inactivated types 1, 2, and 3 poliovirus, D antigens was studied in trial NCT00885157, titled Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly. That Phase 2 trial was completed, enrolled 225 participants in the Philippines, and included healthy volunteers aged 15 months and older.

How was the Phase 2 trial of inactivated types 1, 2, and 3 poliovirus, D antigens designed?

The Phase 2 trial NCT00885157 for inactivated types 1, 2, and 3 poliovirus, D antigens was an active-controlled study comparing a fractional intradermal booster dose of IPV with a full intramuscular dose. It enrolled 225 participants of all sexes in the Philippines and was completed.