Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCV-free liquid formulation of GSK's live attenuated HRV · 1 trial · 1 indication
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
| Arm | Type | Description |
|---|---|---|
| HRV PCV-free Liq Group | EXPERIMENTAL | Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
| HRV Lyo group | ACTIVE_COMPARATOR | Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. |
| Name | Type | Description |
|---|---|---|
| PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine | BIOLOGICAL | 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries. |
| Lyophilized formulation of GSK's oral live attenuated HRV vaccine | BIOLOGICAL | 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries. |
Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: * Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written or ...
It is an investigational oral rotavirus vaccine developed by GSK plc. It is a live attenuated human rotavirus (HRV) vaccine presented as a liquid formulation that does not contain porcine circovirus (PCV). It is being studied for the prevention of rotavirus infections in healthy infants.
It is being developed for the prevention of rotavirus infections in infants. Rotavirus is a leading cause of severe diarrhea in young children. The vaccine is given orally to healthy infants starting at 6 to 12 weeks of age, with the goal of protecting them against rotavirus disease.
The vaccine is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this PCV-free liquid formulation of its live attenuated human rotavirus vaccine in healthy infants.
It is in Phase 3 clinical development. The single Phase 3 trial, NCT03954743, has been completed. The vaccine is investigational and has not been approved by the FDA for any indication. GSK has not announced a regulatory submission for this formulation.
It has been studied in one Phase 3 trial, NCT03954743, titled Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks. The trial enrolled 1,351 healthy infants across the United States, Canada, Hong Kong, Taiwan, and Turkey, and is now completed.
Yes. The PCV-free liquid formulation of GSK's live attenuated HRV vaccine is also known as the PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine. These names refer to the same investigational vaccine candidate developed by GSK plc for rotavirus prevention in infants.