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10 valent pneumococcal conjugate vaccine

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00370318Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant VaccinesPHASE3 COMPLETED 400Sep 1, 2006Apr 1, 2007Mar 23, 201710 Czechia
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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 — 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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