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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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