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Also known as Havrix (investigational formulation)
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...
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 |
Havrix is a vaccine used for the prevention of Hepatitis A, an infectious disease of the liver. It is studied in children from 12 months of age and is given to healthy volunteers to protect against Hepatitis A infection. The clinical program covers immunization in pediatric populations.
Havrix is developed and manufactured by GSK plc, which trades under the ticker GSK. The vaccine is produced by GlaxoSmithKline Biologicals, the company's vaccine division. GSK holds the licensed Hepatitis A vaccine franchise that includes Havrix.
Havrix has completed Phase 3 clinical development. Two Phase 3 trials of the vaccine have been completed, with no active trials currently listed. The studies together enrolled 1,942 participants and were randomized and active controlled.
Havrix has been evaluated in two completed Phase 3 trials. NCT00197236 tested immunogenicity and safety when co-administered with diphtheria, tetanus, pertussis and Haemophilus b vaccines in 468 children aged 15 months in the United States. NCT00197015 studied co-administration with measles, mumps, rubella and varicella vaccines in 1,474 children.
Yes. Havrix is also known as Havrix, GlaxoSmithKline Biologicals' licensed Hepatitis A vaccine, and is written with the registered trademark symbol as Havrix. These names refer to the same GSK Hepatitis A vaccine product, so searches using any of these terms point to the same asset.
Havrix is used for immunization against Hepatitis A in children. Both completed Phase 3 trials enrolled children starting at 12 months of age in the United States, and the studies examined co-administration with routine childhood vaccines such as diphtheria, tetanus, pertussis, Haemophilus b, measles, mumps, rubella and varicella vaccines.