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Live attenuated rotavirus vaccine

Phase 2

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

Live attenuated rotavirus vaccine · 1 trial · 1 indication

Phase 2 1
NCT00137930Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus GastroenteritisInfections, Rotavirus
COMPLETED250 Analytics
PHASE2COMPLETED
Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Infections, RotavirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Endpoint: immunogenicity and reactogenicity
Proportion of subjects with vaccine take

Secondary Endpoints

Proportion of seroconverters
RV-IgA concentration
Occurrence of solicited symptoms: loss of appetite, fussiness/irritability, fever, diarrhea, vomiting, cough/runny nose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Live attenuated rotavirus vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range6 Weeks to 12 Weeks
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination. * Writ...

Countries:Finland
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Frequently asked questions about Live attenuated rotavirus vaccine

What is Live attenuated rotavirus vaccine used for?

Live attenuated rotavirus vaccine is an investigational vaccine being studied for the prophylaxis of rotavirus gastroenteritis, a condition caused by rotavirus infections. It is intended to prevent rotavirus-related illness in susceptible populations, with clinical development focused on assessing its immunogenicity and safety.

Who makes Live attenuated rotavirus vaccine?

Live attenuated rotavirus vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the vaccine's potential for preventing rotavirus gastroenteritis.

What phase is Live attenuated rotavirus vaccine in?

Live attenuated rotavirus vaccine is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine remains under evaluation for its safety and immunogenicity profile.

What clinical trials is Live attenuated rotavirus vaccine in?

Live attenuated rotavirus vaccine has one completed Phase 2 clinical trial registered as NCT00137930. The study, titled 'Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis,' enrolled 250 participants in Finland and evaluated the vaccine's safety and immunogenicity.

Is Live attenuated rotavirus vaccine the same as Human Rotavirus (HRV) vaccine?

Live attenuated rotavirus vaccine is also known as Human Rotavirus (HRV) vaccine. The clinical trial NCT00137930 refers to it as the HRV vaccine, and it is being studied for the prophylaxis of rotavirus gastroenteritis. The vaccine is an investigational product in Phase 2 development.