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2-dose live attenuated G1P human rotavirus vaccine

Phase 3

Infections, Rotavirus | Vaccine | Infectious Disease |GSK plc|Trials Updated: Nov 4, 2016

2-dose live attenuated G1P human rotavirus vaccine target and mechanism

ModalityVaccine

Also known as 2-dose oral live attenuated G1P[8] human rotavirus vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment8,044

FDA Designations

No designations recorded

2-dose live attenuated G1P human rotavirus vaccine clinical trials

2-dose live attenuated G1P human rotavirus vaccine · 3 trials · 1 indication

Phase 3 3
NCT00382772A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).Infections, Rotavirus
COMPLETED1,200 Analytics
NCT00334607Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USAInfections, Rotavirus
COMPLETED484 Analytics
NCT00139347Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy InfantsInfections, Rotavirus
COMPLETED6,360 Analytics
PHASE3COMPLETED
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
Infections, Rotavirus
NCT003827721,200
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PHASE3COMPLETED
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Infections, Rotavirus
NCT00334607484
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PHASE3COMPLETED
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Infections, Rotavirus
NCT001393476,360
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Study Endpoints

Primary Endpoints

Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.

Secondary Endpoints

Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.
Assess immunogenicity and safety of HRV vaccine.
Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
2-dose oral live attenuated G1P[8] human rotavirus vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range11 Weeks to 17 Weeks
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent. Exclusion Criteria: * Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medic...

Countries:FinlandUnited StatesArgentinaBrazilColombiaDominican RepublicHondurasPanama
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Frequently asked questions about 2-dose live attenuated G1P human rotavirus vaccine

What is the 2-dose live attenuated G1P human rotavirus vaccine?

It is an oral vaccine developed by GSK plc (ticker GSK) for preventing rotavirus infections. It is a live attenuated G1P human rotavirus vaccine given in two doses to infants. The vaccine is in Phase 3 clinical development and has been studied in over 8,000 infants across three completed trials.

What is the 2-dose live attenuated G1P human rotavirus vaccine used for?

It is used for the prevention of rotavirus infections in infants. Rotavirus is a leading cause of severe diarrhea in young children. The vaccine is designed to be given orally in a two-dose regimen, and all completed trials enrolled healthy infants starting at 6 to 11 weeks of age.

Who makes the 2-dose live attenuated G1P human rotavirus vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the 2-dose live attenuated G1P human rotavirus vaccine. GSK conducted the Phase 3 clinical program for this vaccine candidate, including trials in Finland, the United States, and several countries in Latin America.

What phase is the 2-dose live attenuated G1P human rotavirus vaccine in?

The 2-dose live attenuated G1P human rotavirus vaccine is in Phase 3 clinical development. Three Phase 3 trials have been completed, with a total enrollment of 8,044 infants. No trials are currently active. The vaccine is investigational and has not been approved by the FDA.

What clinical trials is the 2-dose live attenuated G1P human rotavirus vaccine in?

Three completed Phase 3 trials have evaluated this vaccine: NCT00382772 in Finland with 1,200 infants, NCT00334607 in the United States with 484 infants, and NCT00139347 in Argentina, Brazil, Colombia, the Dominican Republic, Honduras, and Panama with 6,360 infants. All trials studied healthy infants.

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