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10 valent pneumococcal conjugate

Phase 3

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment390

FDA Designations

No designations recorded

Clinical trial landscape

10 valent pneumococcal conjugate · 1 trial · 1 indication

Phase 3 1
NCT00370227Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate VaccineInfections, Streptococcal
COMPLETED390 Analytics
PHASE3COMPLETED
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Infections, StreptococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Post vacc: rectal fever >39°C

Secondary Endpoints

AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
10 valent pneumococcal conjugate (vaccine)BIOLOGICAL -
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Eligibility Criteria

Age Range12 Months to 14 Months
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: * use ...

Countries:Finland
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Frequently asked questions about 10 valent pneumococcal conjugate

What is the 10-valent pneumococcal conjugate vaccine used for?

The 10-valent pneumococcal conjugate vaccine is used to prevent infections caused by Streptococcus pneumoniae. It is being studied in healthy infants and toddlers to assess its safety and immunogenicity when given as a booster dose or alongside standard infant vaccines.

Who is developing the 10-valent pneumococcal conjugate vaccine?

The 10-valent pneumococcal conjugate vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is the 10-valent pneumococcal conjugate vaccine in?

The 10-valent pneumococcal conjugate vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use and is still undergoing clinical trials to evaluate its safety and effectiveness.

What clinical trials is the 10-valent pneumococcal conjugate vaccine in?

The 10-valent pneumococcal conjugate vaccine has completed two Phase 3 trials. One trial, NCT00370227, studied a booster dose in 390 children in Finland. Another trial, NCT00370318, evaluated prophylactic antipyretic treatment in 400 children receiving the vaccine with standard infant vaccines in Czechia.

What does the 10-valent pneumococcal conjugate vaccine target?

The 10-valent pneumococcal conjugate vaccine targets Streptococcus pneumoniae, the bacterium responsible for pneumococcal infections. It is designed to elicit an immune response against this pathogen to help prevent related diseases.