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10 valent pneumococcal conjugate vaccine

Phase 3

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Mar 23, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

10 valent pneumococcal conjugate vaccine · 1 trial · 1 indication

Phase 3 1
NCT00370318Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant VaccinesInfections, Rotavirus
COMPLETED400 Analytics
PHASE3COMPLETED
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
Infections, RotavirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of fever > or = to 38°C (rectal temperature)

Secondary Endpoints

Safety, reactogenicity and immunogenicity pre and post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
10 valent pneumococcal conjugate vaccineBIOLOGICAL -
Infanrix HexaBIOLOGICAL -
RotarixBIOLOGICAL -
ParacetamolDRUG -
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Eligibility Criteria

Age Range9 Weeks to 16 Weeks
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks. Exclusion Criteria: * Body weight \< 4.5 kg * Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune mo...

Countries:Czechia
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Frequently asked questions about 10 valent pneumococcal conjugate vaccine

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.