Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals 2-dose inactivated hepatitis A vaccine · 1 trial · 1 indication
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Havrix Group | ACTIVE_COMPARATOR | Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9. |
| Havrix+Prevnar Group | EXPERIMENTAL | Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9. |
| Prevnar Havrix Group | ACTIVE_COMPARATOR | Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) | BIOLOGICAL | Two doses, administered intramuscularly in the right anterolateral thigh. |
| Prevnar™ | BIOLOGICAL | One dose, administered intramuscularly in the left anterolateral thigh. |
Inclusion Criteria: * A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase, * Free of obvious health problems, * Subjects must have previously received three doses of Prevnar in his/her first year of life. Exclusion Criteria: * Use of any investigational or...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
The GSK Biologicals 2-dose inactivated hepatitis A vaccine is a vaccine developed by GSK plc to protect against hepatitis A, a viral infection of the liver. It is given as a two-dose inactivated vaccine series and is also known as Havrix. It is studied in healthy children and other populations.
It is used for immunization against hepatitis A virus infection. The vaccine is designed to prevent hepatitis A, an infectious disease of the liver, and has been evaluated in healthy children from 12 months of age. It is administered as a two-dose inactivated vaccine regimen.
GSK plc, which trades under the ticker GSK, develops and makes the GSK Biologicals 2-dose inactivated hepatitis A vaccine, also known as Havrix. GSK Biologicals is the vaccine business of GSK plc.
The GSK Biologicals 2-dose inactivated hepatitis A vaccine has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is an inactivated hepatitis A vaccine candidate evaluated in healthy children.
The vaccine has been evaluated in one completed Phase 3 trial, NCT00197002, titled Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age. The trial enrolled 521 participants in the United States, was randomized and active controlled, and included healthy volunteers from 12 months of age.
Yes. Havrix is another name for the GSK Biologicals 2-dose inactivated hepatitis A vaccine. Both names refer to the same inactivated hepatitis A vaccine developed by GSK plc, so readers searching for Havrix will find information about this vaccine.