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2-dose live attenuated G1P human rotavirus vaccine

Phase 3

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Nov 4, 2016

Target and mechanism

ModalityMonoclonal antibody

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

Clinical trial landscape

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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