Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis A Vaccine, Purified Inactivated · 1 trial · 1 indication
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer \< 50 mIU/mL.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | VAQTA™ |
| Name | Type | Description |
|---|---|---|
| Hepatitis A Vaccine, Purified Inactivated (VAQTA™) | BIOLOGICAL | Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6. |
Inclusion Criteria: * Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination Exclusion Criteria: * Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection * Subject has a fever 72 hours prior to first injection * Subjec...
Hepatitis A Vaccine, Purified Inactivated is used for the prevention of Hepatitis A Virus Infection. It is an investigational vaccine being studied in healthy children aged 12 to 23 months. The vaccine is designed to protect against the hepatitis A virus, which causes liver infection.
Hepatitis A Vaccine, Purified Inactivated is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.
Hepatitis A Vaccine, Purified Inactivated is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess the vaccine's performance in healthy children.
Hepatitis A Vaccine, Purified Inactivated is being studied in a Phase 3 clinical trial with the identifier NCT00835380. The trial, titled 'A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)', enrolled 80 participants and has been completed. The study evaluated the vaccine in healthy children.
Hepatitis A Vaccine, Purified Inactivated is associated with the brand name VAQTA, as indicated by the clinical trial title referencing VAQTA™. The trial evaluates two doses of VAQTA in healthy children, suggesting that the purified inactivated vaccine is the active component of this product.