Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Twinrix · 2 trials · 3 indications
The rSBA titers were expressed as geometric mean titers (GMTs).
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.
Cut-off values were defined 3.3 mIU/mL for the in-house anti-HBs assay and 6.2 mIU/mL for the ChemiLuminescence ImmunoAssay, which was also considered as seropositivity, and 10 mIU/mL.
Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL. The laboratory assay was changed from Year 13 to Year 14 to in-house ELISA and at Year 15 to CLIA for anti-HBs GMCs.Thus for the sake of bridging, blood samples corresponding to Year 14 previously tested with ELISA were re-tested with CLIA (Year 14\*).
Subjects who lost seroprotective concentrations for anti-HBs (\< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15. Two subjects were eligible for this after Year 11. 3.29 in the table means a concentration of \< 3.3 mIU/mL. As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion.
Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose. Anamnestic response was defined as: * post-additional vaccination anti-HBs concentration \>= 10 mIU/mL in subject seronegative before additional dose. * 4-fold increase post-additional dose compared to pre-additional vaccine time point.
Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| Arm | Type | Description |
|---|---|---|
| Nimenrix + Twinrix Group | EXPERIMENTAL | Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
| Nimenrix Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Nimenrix™ vaccine at Month 0. |
| Twinrix Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
| Group A | EXPERIMENTAL | Was vaccinated with Lot A in the primary study. |
| Group B | EXPERIMENTAL | Was vaccinated with Lot B in the primary study. |
| Group C | EXPERIMENTAL | Was vaccinated with Lot C in the primary study. |
| Name | Type | Description |
|---|---|---|
| Nimenrix (Meningococcal vaccine 134612) | BIOLOGICAL | Single dose intramuscular injection |
| Twinrix | BIOLOGICAL | 3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age. |
| Twinrix™ | BIOLOGICAL | Intramuscular injection, 3 doses |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol * A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine. * Written informed consent obta...
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 |
Twinrix is a combined vaccine developed by GSK plc for protection against hepatitis A and hepatitis B. It is studied in healthy adults and adolescents, including long-term immune persistence after a 0, 1, 6 month schedule. GSK's related meningococcal vaccine program 134612 has also been studied in Phase 3 trials in Denmark and Sweden.
Twinrix is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK conducted the Phase 3 hepatitis A and B vaccine persistence study NCT00289770 in Belgium, as well as the Phase 3 meningococcal vaccine study NCT00465816 in Denmark and Sweden.
Twinrix has been evaluated in Phase 3 clinical trials. The completed Phase 3 study NCT00289770 assessed long-term immune persistence of the combined hepatitis A and B vaccine in healthy adults in Belgium. A separate completed Phase 3 study, NCT00465816, enrolled 611 participants for a meningococcal vaccine.
Twinrix has been studied in completed Phase 3 trials. NCT00289770 evaluated long-term immune persistence of the combined hepatitis A and B vaccine in 50 healthy adults in Belgium. NCT00465816 was a randomized, controlled Phase 3 study of GSK's meningococcal vaccine 134612 in 611 participants in Denmark and Sweden.
Yes, Twinrix and Twinrix™ refer to the same GSK plc vaccine product. The trademark symbol is simply a stylized form of the same name. Both refer to the combined hepatitis A and B vaccine developed by GSK.