Recent Updates
Recently added Catalysts

Human rotavirus liquid vaccine

Phase 3

Infections, Rotavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 28, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment375

FDA Designations

No designations recorded

Clinical trial landscape

Human rotavirus liquid vaccine · 1 trial · 1 indication

Phase 3 1
NCT00345956To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)Infections, Rotavirus
COMPLETED375 Analytics
PHASE3COMPLETED
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Infections, RotavirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Human rotavirus liquid vaccineBIOLOGICAL -
Unlock Study Design Details

Eligibility Criteria

Age Range6 Weeks to 10 Weeks
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams. * Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: * Use of any investigational or non-registered product (drug ...

Countries:Vietnam
Unlock Eligibility Criteria

Frequently asked questions about Human rotavirus liquid vaccine

What is Human rotavirus liquid vaccine used for?

Human rotavirus liquid vaccine is an investigational vaccine being studied for the prevention of rotavirus infections, which cause severe diarrhea in infants and young children. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes Human rotavirus liquid vaccine?

Human rotavirus liquid vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical trials for rotavirus infection prevention.

What phase is Human rotavirus liquid vaccine in?

Human rotavirus liquid vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. A Phase 3 trial has been completed, evaluating the vaccine's immunogenicity, reactogenicity, and safety in infants.

What clinical trials is Human rotavirus liquid vaccine in?

Human rotavirus liquid vaccine has one completed Phase 3 clinical trial, NCT00345956, which evaluated the immunogenicity, reactogenicity, and safety of two doses of the vaccine in infants in Vietnam. The trial enrolled 375 participants, all healthy infants aged 6 weeks and older.

Is Human rotavirus liquid vaccine a monoclonal antibody?

Human rotavirus liquid vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine to prevent rotavirus infection. It is currently in Phase 3 clinical trials and remains investigational, with no approval status confirmed.