Recent Updates
Recently added Catalysts

Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Phase 2

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Aug 24, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment882

FDA Designations

No designations recorded

Clinical trial landscape

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 Meningitis
NCT00355121882
Unlock 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
Unlock Study Endpoints

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)
Unlock Study Design Details

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
Unlock Eligibility Criteria

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 meningococcal meningitis, a serious bacterial infection of the membranes surrounding the brain and spinal cord. It is being studied in children aged 4 to 6 years, and the clinical trial also covers related conditions including tetanus, diphtheria, pertussis, and poliomyelitis.

Who makes Polysaccharide Diphtheria Toxoid Conjugate Vaccine?

Sanofi (ticker: SNY) is developing Polysaccharide Diphtheria Toxoid Conjugate Vaccine. The company is conducting clinical research on this vaccine for the prevention of meningococcal meningitis in pediatric populations.

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, meaning it has not yet been approved for commercial use and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is Polysaccharide Diphtheria Toxoid Conjugate Vaccine in?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is being studied in a completed Phase 2 trial with the identifier NCT00355121. This randomized, double-blind, controlled study enrolled 882 participants in the United States, examining the vaccine when administered concomitantly with a fifth dose of DAPTACEL in children aged 4 to 6 years.

Is Polysaccharide Diphtheria Toxoid Conjugate Vaccine the same as Menactra?

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is being studied in a clinical trial titled 'Study of Menactra in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL.' The trial evaluates this vaccine in the context of Menactra, a meningococcal conjugate vaccine.