Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Havrix · 2 trials · 1 indication
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.
Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Havrix Group | ACTIVE_COMPARATOR | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | EXPERIMENTAL | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix + Infanrix + ActHIB Group | ACTIVE_COMPARATOR | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| HAV Group | ACTIVE_COMPARATOR | Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9) |
| HAV+MMR+V Group | EXPERIMENTAL | Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9 |
| MMR+V→HAV Group | ACTIVE_COMPARATOR | Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5) |
| Name | Type | Description |
|---|---|---|
| Havrix™ | BIOLOGICAL | 2 intramuscular injections, 6 months apart |
| Infanrix™ | BIOLOGICAL | 1 intramuscular injection |
| ActHIB™ | BIOLOGICAL | 1 intramuscular injection |
| Havrix® | BIOLOGICAL | 2 doses administered intramuscularly |
| M-M-R®II | BIOLOGICAL | 1 dose administered subcutaneously |
| VARIVAX® | BIOLOGICAL | 1 dose administered subcutaneously |
Inclusion Criteria: * Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol * A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase, * Subjects must have previously received three doses e...
Havrix is a vaccine used for Hepatitis A. It is being developed by GSK plc for the prevention of Hepatitis A infection. The drug is currently in Phase 3 clinical development and is intended for use in children as young as 12 months.
Havrix is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in pediatric populations.
Havrix is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 1,942 participants. The trials were active-controlled and not double-blinded, and they evaluated the vaccine's safety and immunogenicity in children.
Havrix has been studied in two completed Phase 3 trials. NCT00197015 evaluated co-administration with measles, mumps, rubella, and varicella vaccines in 1,474 children. NCT00197236 assessed co-administration with diphtheria, tetanus, pertussis, and Haemophilus b vaccines in 468 children.
Havrix is an investigational vaccine currently in Phase 3 clinical development. It has not been reported as FDA approved. The completed trials have focused on immunogenicity and safety in healthy children aged 12 months and older.