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GSK Biologicals' human rotavirus vaccine 444563

Phase 1

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 19, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' human rotavirus vaccine 444563 · 1 trial · 1 indication

Phase 1 1
NCT01107587Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy InfantsInfections, Rotavirus
COMPLETED50 Analytics
PHASE1COMPLETED
Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
Infections, Rotavirus
NCT0110758750
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Study Endpoints

Primary Endpoints

Occurrence of grade 3 solicited adverse events.
Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.

Secondary Endpoints

Occurrence of each solicited adverse event.
Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Occurrence of unsolicited adverse events.
Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.
Occurrence of serious adverse events.
Throughout the study period (Day 0 to Month 2).
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
HRV groupEXPERIMENTALSubjects will receive GSK Biologicals' human rotavirus vaccine 444563.
Placebo GroupPLACEBO_COMPARATORSubjects will receive placebo.

Interventions

NameTypeDescription
GSK Biologicals' human rotavirus vaccine 444563BIOLOGICALOral, two doses.
PlaceboBIOLOGICALOral, two doses.
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Eligibility Criteria

Age Range6 Weeks to 16 Weeks
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccin...

Countries:China
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Frequently asked questions about GSK Biologicals' human rotavirus vaccine 444563

What is GSK Biologicals' human rotavirus vaccine 444563 used for?

GSK Biologicals' human rotavirus vaccine 444563 is an investigational vaccine being developed for the prevention of rotavirus infections, which cause severe diarrhea in infants and young children. It is currently in Phase 1 clinical development and has not been approved for use.

Who makes GSK Biologicals' human rotavirus vaccine 444563?

GSK Biologicals' human rotavirus vaccine 444563 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is in Phase 1 clinical development for rotavirus infections.

What phase is GSK Biologicals' human rotavirus vaccine 444563 in?

GSK Biologicals' human rotavirus vaccine 444563 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is GSK Biologicals' human rotavirus vaccine 444563 in?

GSK Biologicals' human rotavirus vaccine 444563 has one completed clinical trial, NCT01107587, titled 'Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants.' This Phase 1 trial enrolled 50 healthy infants in China and was placebo-controlled, randomized, and double-blind.

Is GSK Biologicals' human rotavirus vaccine 444563 a monoclonal antibody?

GSK Biologicals' human rotavirus vaccine 444563 is classified as a monoclonal antibody modality, though it is being studied as a vaccine for rotavirus infections. It is currently in Phase 1 clinical development and is not yet approved.