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Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Phase 3

Meningococcal Meningitis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Aug 24, 2011

Polysaccharide Diphtheria Toxoid Conjugate Vaccine development status

Highest phase Phase 3 (NCT00255047)
Phase scored for SNYPhase 2
Registered trials 7 across 3 sponsors since Sep 2005

Polysaccharide Diphtheria Toxoid Conjugate Vaccine target and mechanism

ModalityVaccine

Also known as Menactra®, DAPTACEL®, IPOL

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment882

FDA Designations

No designations recorded

Polysaccharide Diphtheria Toxoid Conjugate Vaccine clinical trials

Polysaccharide Diphtheria Toxoid Conjugate Vaccine · 1 trial · 5 indications

Phase 2 1
NCT00355121Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®Meningococcal Meningitis
COMPLETED882 Analytics
PHASE2COMPLETED
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Meningococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Day 30 post-vaccination (Visit 1)

Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Day 30 post-vaccination (Visit 1)

Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Secondary Endpoints

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Day 0 through Day 7 post-vaccination at Visit 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALDAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Group 2EXPERIMENTALDAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Group 3EXPERIMENTALMenactra® + IPOL on Day 0 and DAPTACEL® on Day 30

Interventions

NameTypeDescription
Polysaccharide Diphtheria Toxoid Conjugate VaccineBIOLOGICAL0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
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Eligibility Criteria

Age Range4 Years to 7 Years
SexALL
Healthy VolunteersYes
Study Sites26

Inclusion Criteria: * Healthy, as determined by medical history and physical examination. * Aged 4 to \< 7 years at the time of study vaccination on Day 0. * Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. * Prev...

Countries:United States
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Frequently asked questions about Polysaccharide Diphtheria Toxoid Conjugate Vaccine

What is Polysaccharide Diphtheria Toxoid Conjugate Vaccine used for?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is used for the prevention of meningococcal meningitis. It is a vaccine developed by Sanofi. The vaccine is designed to protect against meningococcal disease, which can cause meningitis. It is given to children and adults to prevent infection.

Who makes Polysaccharide Diphtheria Toxoid Conjugate Vaccine?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is made by Sanofi, which trades under the ticker symbol SNY. Sanofi is a global pharmaceutical company that develops and manufactures vaccines and other medicines. The vaccine is part of Sanofi's portfolio of infectious disease products.

What phase is Polysaccharide Diphtheria Toxoid Conjugate Vaccine in?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial has been completed, and further studies may be needed to support potential approval.

What clinical trials is Polysaccharide Diphtheria Toxoid Conjugate Vaccine in?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine has been studied in a completed Phase 2 clinical trial, NCT00355121. The trial enrolled 882 children aged 4 to 6 years in the United States and evaluated the vaccine when given with a fifth dose of DAPTACEL. The trial was randomized, double-blind, and controlled.

Is Polysaccharide Diphtheria Toxoid Conjugate Vaccine the same as Menactra?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is also known as Menactra. Menactra is a vaccine used to prevent meningococcal meningitis. It is developed by Sanofi and has been studied in clinical trials for use in children and adults.