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Polysaccharide Diphtheria Conjugate Vaccine

Phase 2

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Feb 14, 2014

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment234

FDA Designations

No designations recorded

Clinical trial landscape

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 Polysaccharide Diphtheria Conjugate Vaccine used for?

Polysaccharide Diphtheria Conjugate Vaccine is used for meningitis and meningococcal infection. It is an investigational vaccine being developed by Sanofi (SNY) and is currently in Phase 2 clinical development. The vaccine is intended to help prevent these serious infectious diseases.

Who makes Polysaccharide Diphtheria Conjugate Vaccine?

Sanofi (SNY) is developing Polysaccharide Diphtheria Conjugate Vaccine. The vaccine is currently in Phase 2 clinical development for the prevention of meningitis and meningococcal infection. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is Polysaccharide Diphtheria Conjugate Vaccine in?

Polysaccharide Diphtheria Conjugate Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied for use in meningitis and meningococcal infection, with one completed Phase 2 trial.

What clinical trials is Polysaccharide Diphtheria Conjugate Vaccine in?

Polysaccharide Diphtheria Conjugate Vaccine has one completed clinical trial, NCT00258856. This Phase 2 study, titled "Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®," enrolled 234 participants in the United States and evaluated antibody persistence related to meningitis and meningococcal infection.

Is Polysaccharide Diphtheria Conjugate Vaccine the same as Menactra or Menomune?

Polysaccharide Diphtheria Conjugate Vaccine is not the same as Menactra or Menomune. The clinical trial NCT00258856 studied children who previously received Menactra or Menomune to assess antibody persistence, but the vaccine itself is a distinct investigational product being developed by Sanofi for meningitis and meningococcal infection.