Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Prevenar 13
Prevnar · 2 trials · 2 indications
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. |
| Group A | EXPERIMENTAL | Human Rotavirus Vaccine - Formulation 1 |
| Group B | EXPERIMENTAL | Human Rotavirus Vaccine - Formulation 2 |
| Group C | PLACEBO_COMPARATOR | - |
| 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. |
| Human Rotavirus Vaccine - two different formulations | BIOLOGICAL | Two oral doses |
| Prevnar | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| IPOL | BIOLOGICAL | Two-dose intramuscular injection (US subjects only) |
| Infanrix | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| OmniHIB | BIOLOGICAL | Three-dose intramuscular injection (US subjects only) |
| Pentacel | BIOLOGICAL | Three-dose intramuscular injection (Canada only) |
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...
Prevnar is a pneumococcal vaccine being studied for use in preventing infections, including meningococcal infections, hepatitis A, and rotavirus infections. It is currently in Phase 3 clinical development as an investigational product and has not been approved for these indications.
Prevnar is developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy infants and children.
Prevnar is in Phase 3 clinical development. It has completed multiple trials, including Phase 3 studies for hepatitis A and meningococcal infections, as well as a Phase 2 study for rotavirus infections. The vaccine remains investigational and is not yet approved.
Prevnar has been studied in clinical trials including NCT00197002, a Phase 3 study of a hepatitis A vaccine given with a pneumococcal vaccine in healthy children, and NCT03621670, a Phase 3 study of a meningococcal group B vaccine and 13-valent pneumococcal vaccine in healthy infants. These trials are completed.
Yes, Prevnar is also known as Prevenar 13. This alternative name is used in some clinical and commercial contexts to refer to the same 13-valent pneumococcal vaccine product being developed by GSK plc.