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Td vaccine

Phase 2/3

Diphtheria | Vaccines | Other |Sanofi|Trials Updated: Aug 27, 2020

Td vaccine target and mechanism

ModalityVaccines

Also known as Td

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

Td vaccine clinical trials

Td vaccine · 1 trial · 1 indication

Phase 2/3 1
NCT00553228Pertussis Maternal Immunization StudyPregnant Women
COMPLETED320 Analytics
PHASE2/PHASE3COMPLETED
Pertussis Maternal Immunization Study
Pregnant WomenUnlock trial analytics

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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Frequently asked questions about Td vaccine

What is Td vaccine used for?

Td vaccine is a diphtheria and tetanus combined vaccine for adults and adolescents, given as an adsorbed formulation. It is studied for protection against diphtheria. The recorded clinical program includes a Phase 2 study in pregnant women conducted in Canada.

Who makes the Td vaccine?

Sanofi makes the Td vaccine, which is also known as Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed. Sanofi trades under the ticker SNY. The product is a combined diphtheria and tetanus vaccine formulated for adult and adolescent use.

What phase is the Td vaccine in?

The Td vaccine is in Phase 2 development. Its single recorded trial, NCT00553228, is a completed Phase 2 study. The vaccine is investigational in this program and is being studied in pregnant women for diphtheria protection.

What clinical trials is the Td vaccine in?

The Td vaccine has been studied in NCT00553228, titled Pertussis Maternal Immunization Study. It was a completed Phase 2 trial that enrolled 320 participants, all female, aged 18 years and older, in Canada. The trial was randomized, double-blind, active-controlled, and enrolled healthy volunteers.