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10 valent pneumococcal conjugate vaccine

Phase 3

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

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2006

Target and mechanism

ModalityVaccine

Also known as 10 valent pneumococcal conjugate (vaccine), 10 valent pneumococcal conjugate

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 · 2 trials · 2 indications

Phase 3 2
NCT00370227Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate VaccineInfections, Streptococcal
COMPLETED390 Analytics
NCT00370318Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant VaccinesInfections, Rotavirus
COMPLETED400 Analytics
PHASE3COMPLETED
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Infections, StreptococcalUnlock trial analytics
PHASE3COMPLETED
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
Infections, RotavirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Post vacc: rectal fever >39°C
Occurrence of fever > or = to 38°C (rectal temperature)

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.
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 (vaccine)BIOLOGICAL -
10 valent pneumococcal conjugate vaccineBIOLOGICAL -
Infanrix HexaBIOLOGICAL -
RotarixBIOLOGICAL -
ParacetamolDRUG -
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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:FinlandCzechia
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Frequently asked questions about 10 valent pneumococcal conjugate vaccine

What is the 10 valent pneumococcal conjugate vaccine?

The 10 valent pneumococcal conjugate vaccine is an investigational vaccine developed by GSK plc for preventing streptococcal and other infections. It is designed to protect against ten pneumococcal serotypes and has been studied in infants and young children, including as a booster dose following primary vaccination.

What is the 10 valent pneumococcal conjugate vaccine used for?

It is being developed for the prevention of pneumococcal infections, including streptococcal infections, in young children. Clinical studies have evaluated its use alongside standard infant vaccines and as a booster dose in children from 12 months of age, with healthy volunteers enrolled in the trials.

Who makes the 10 valent pneumococcal conjugate vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the 10 valent pneumococcal conjugate vaccine. The vaccine is part of GSK's pneumococcal conjugate vaccine program and has been evaluated in Phase 3 clinical studies conducted in Europe.

What phase is the 10 valent pneumococcal conjugate vaccine in?

The 10 valent pneumococcal conjugate vaccine is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Its completed Phase 3 trials enrolled approximately 400 and 390 participants respectively, and no active trials are currently listed for this asset.

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

Two completed Phase 3 trials have studied the vaccine. NCT00370318 evaluated prophylactic antipyretic treatment in children receiving pneumococcal conjugate and standard infant vaccines in Czechia, enrolling 400 participants. NCT00370227 assessed the safety and immunogenicity of a booster dose in Finland, enrolling 390 participants from 12 months of age.

Is the 10 valent pneumococcal conjugate vaccine the same as 10 valent pneumococcal conjugate?

Yes. The 10 valent pneumococcal conjugate vaccine is also referred to as 10 valent pneumococcal conjugate (vaccine) or simply 10 valent pneumococcal conjugate. These names refer to the same GSK plc vaccine candidate in Phase 3 development for pneumococcal and streptococcal infections.