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Td

Phase 2

Pregnant Women | Monoclonal antibody | Other |Sanofi|Last Updated: Aug 27, 2020

Target and mechanism

ModalityMonoclonal antibody

Also known as Td vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

Td · 1 trial · 1 indication

Phase 2 1
NCT00553228Pertussis Maternal Immunization StudyPregnant Women
COMPLETED320 Analytics
PHASE2COMPLETED
Pertussis Maternal Immunization Study
Pregnant Women
NCT00553228320
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Study Endpoints

Primary Endpoints

Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups
birth, 2, 4, 6, 7, 12, and 13 months of age

Secondary Endpoints

Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment.
developmental screening at 1 year of age
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
group IEXPERIMENTALTdap
group 2ACTIVE_COMPARATORTd

Interventions

NameTypeDescription
TdapBIOLOGICAL0.5 mL IM once at visit #2
TdBIOLOGICAL0.5 mL IM once at visit #2
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Pregnant women 18 years of age and over. * Women who, at ≥30-\<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form. * Signed, informed consent. Exclus...

Countries:Canada
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