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Rotavirus

Phase 3

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Dec 30, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment78,229

FDA Designations

No designations recorded

Clinical trial landscape

Rotavirus · 5 trials · 2 indications

Phase 3 3Phase 2 2
NCT00140686To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood VaccinesInfections, Rotavirus
COMPLETED3,994 Analytics
NCT00197210A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy InfantsInfections, Rotavirus
COMPLETED10,708 Analytics
NCT00140673A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.Infections, Rotavirus
COMPLETED63,227 Analytics
PHASE3COMPLETED
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
Infections, Rotavirus
NCT001406863,994
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PHASE3COMPLETED
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Infections, Rotavirus
NCT0019721010,708
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PHASE3COMPLETED
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
Infections, Rotavirus
NCT0014067363,227
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Study Endpoints

Primary Endpoints

Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
Seroprotection for each polio serotype 1 month after the 3rd dose.

Secondary Endpoints

Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Rotavirus (vaccine)BIOLOGICAL -
RotavirusBIOLOGICAL -
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Eligibility Criteria

Age Range6 Weeks to 14 Weeks
SexALL
Healthy VolunteersYes
Study Sites101

Inclusion criteria: * Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight \> 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary c...

Countries:CzechiaFinlandFranceGermanyItalySpainSingaporeArgentinaBrazilChileColombiaDominican RepublicHondurasMexicoNicaraguaPanamaPeruVenezuelaBangladeshSouth Africa
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Frequently asked questions about Rotavirus

What is Rotavirus used for?

Rotavirus is an investigational oral live attenuated human rotavirus vaccine being developed by GSK plc for the prevention of rotavirus infections in healthy infants. It is designed to be administered in two doses, with or without co-administration with other childhood vaccines such as oral polio vaccine or inactivated polio vaccine.

Who makes Rotavirus?

Rotavirus is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

What phase is Rotavirus in?

Rotavirus is in Phase 3 clinical development. It has completed four clinical trials, including two Phase 3 studies and two Phase 2 studies, with a total enrollment of 78,229 participants. The vaccine remains investigational and is not yet approved for commercial use.

What clinical trials is Rotavirus in?

Rotavirus has completed four clinical trials: NCT00139334, a Phase 2 study in Bangladesh with 300 infants; NCT00140686, a Phase 3 study in Europe with 3,994 infants; NCT00197210, a Phase 3 study in Singapore with 10,708 infants; and NCT00346892, a Phase 2 study in South Africa with 450 infants.

Is Rotavirus the same as HRV vaccine?

Yes, Rotavirus is also known as the HRV vaccine, which stands for human rotavirus vaccine. In clinical trials, it is referred to as GSK Biologicals' oral live attenuated human rotavirus vaccine. The vaccine is administered orally in two doses to healthy infants starting at 5 to 6 weeks of age.