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Polysaccharide Diphtheria Conjugate Vaccine

Phase 2

Meningitis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Feb 14, 2014

Polysaccharide Diphtheria Conjugate Vaccine development status

Highest phase Phase 2
Registered trials 4 across 2 sponsors since Nov 2005

Polysaccharide Diphtheria Conjugate Vaccine target and mechanism

ModalityVaccine

Also known as Menactra®

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment234

FDA Designations

No designations recorded

Polysaccharide Diphtheria Conjugate Vaccine clinical trials

Polysaccharide Diphtheria Conjugate Vaccine · 1 trial · 2 indications

Phase 2 1
NCT00258856Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®Meningitis
COMPLETED234 Analytics
PHASE2COMPLETED
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
7 or 14 days post-vaccination

Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® Group 1EXPERIMENTALParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.
Menactra® Group 2EXPERIMENTALParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.
Meningococcal Vaccine-naïve Group 3EXPERIMENTALParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
Meningococcal Vaccine-naïve Group 4EXPERIMENTALParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.

Interventions

NameTypeDescription
Polysaccharide Diphtheria Conjugate VaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range7 Years to 15 Years
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion Criteria: * Subject is healthy, as determined by medical history. * Subject is between the ages of 7 and 15 years (not yet 16 years). * For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. * The date of ...

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

What is the Polysaccharide Diphtheria Conjugate Vaccine used for?

The Polysaccharide Diphtheria Conjugate Vaccine is being developed for the prevention of meningitis. It is a vaccine candidate studied in children and is intended to protect against meningococcal infection. Sanofi is developing the vaccine, which has been evaluated in a Phase 2 clinical trial.

Who makes the Polysaccharide Diphtheria Conjugate Vaccine?

Sanofi develops the Polysaccharide Diphtheria Conjugate Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the clinical program evaluating this meningococcal vaccine candidate.

What phase is the Polysaccharide Diphtheria Conjugate Vaccine in?

The Polysaccharide Diphtheria Conjugate Vaccine is in Phase 2 development. It is an investigational vaccine and is not approved. One Phase 2 trial has been completed, and no trials are currently active.

What clinical trials is the Polysaccharide Diphtheria Conjugate Vaccine in?

The Polysaccharide Diphtheria Conjugate Vaccine has been studied in one completed Phase 2 trial, NCT00258856. The trial enrolled 234 children aged 7 to 15 years in the United States and examined antibody persistence in children who previously received one dose of Menactra or Menomune.

Is the Polysaccharide Diphtheria Conjugate Vaccine the same as Menactra?

Menactra is a brand name associated with the Polysaccharide Diphtheria Conjugate Vaccine. The completed Phase 2 trial NCT00258856 evaluated antibody persistence in children who had previously received one dose of Menactra or Menomune, linking the vaccine candidate to the Menactra name.