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Pneumo 23

Phase 3

Streptococcus Pneumoniae | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jun 18, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment339

FDA Designations

No designations recorded

Clinical trial landscape

Pneumo 23 · 1 trial · 1 indication

Phase 3 1
NCT00594347Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With PrevnarStreptococcus Pneumoniae
COMPLETED339 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
Streptococcus PneumoniaeUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
30 days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALPneumo 23
Group BACTIVE_COMPARATORPrevnar

Interventions

NameTypeDescription
Pneumo 23BIOLOGICALVaccine (Pneumo 23)
PrevnarBIOLOGICALVaccine (Prevnar)
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 12 to 18 months on the day of inclusion * Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate * Ch...

Countries:Thailand
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Frequently asked questions about Pneumo 23

What is Pneumo 23 used for?

Pneumo 23 is a vaccine used for Streptococcus pneumoniae, a bacterium that causes infections such as pneumonia, meningitis, and sepsis. It is being studied in children to assess the immunogenicity and safety of a booster dose. The vaccine is currently in Phase 3 clinical development.

Who makes Pneumo 23?

Pneumo 23 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.

What phase is Pneumo 23 in?

Pneumo 23 is in Phase 3 clinical development. A Phase 3 trial has been completed, which evaluated the immunogenicity and safety of a booster dose in children aged 12 to 18 months who were previously primed with Prevnar. The vaccine is investigational and not yet approved.

What clinical trials is Pneumo 23 in?

Pneumo 23 has one completed Phase 3 trial registered under NCT00594347. This trial enrolled 339 participants in Thailand and assessed the immunogenicity and safety of a booster dose in children aged 12 to 18 months primed with Prevnar. The study was randomized, double-blind, and active-controlled.

Is Pneumo 23 a monoclonal antibody?

No, Pneumo 23 is classified as a vaccine, not a monoclonal antibody. It is designed to prevent Streptococcus pneumoniae infections by stimulating the immune system. The vaccine is being studied in a Phase 3 clinical trial to evaluate its safety and immunogenicity in children.