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Human Rotavirus Vaccine- two different formulations

Phase 2

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 16, 2016

Target and mechanism

ModalityMonoclonal antibody

Also known as Human Rotavirus Vaccine - two different formulations

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment529

FDA Designations

No designations recorded

Clinical trial landscape

Human Rotavirus Vaccine- two different formulations · 1 trial · 1 indication

Phase 2 1
NCT00729001Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.Infections, Rotavirus
COMPLETED529 Analytics
PHASE2COMPLETED
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
Infections, Rotavirus
NCT00729001529
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Study Endpoints

Primary Endpoints

Proportion of subjects with vaccine take
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Within the 15-day solicited follow-up period after any dose of study vaccine.

Secondary Endpoints

Occurrence of each type of solicited symptoms
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Throughout the entire study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALHuman Rotavirus Vaccine - Formulation 1
Group BEXPERIMENTALHuman Rotavirus Vaccine - Formulation 2
Group CPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Human Rotavirus Vaccine - two different formulationsBIOLOGICALTwo oral doses
PrevnarBIOLOGICALThree-dose intramuscular injection (US subjects only)
IPOLBIOLOGICALTwo-dose intramuscular injection (US subjects only)
InfanrixBIOLOGICALThree-dose intramuscular injection (US subjects only)
OmniHIBBIOLOGICALThree-dose intramuscular injection (US subjects only)
PentacelBIOLOGICALThree-dose intramuscular injection (Canada only)
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Eligibility Criteria

Age Range6 Weeks to 12 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtain...

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