Drugs / Hepatitis B
Hepatitis B
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Hexyon | — | 2013-02-22 | europa.eu ↗ |
| Approved | EU (EMA) | Infanrix HepB | — | 1997-07-30 | europa.eu ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00871338 | Jun 2009 → Mar 2010 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00505063 | Jul 2007 → Jun 2025 | childhood malignant neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00379977 | Sep → Dec 2006 | diphtheria, haemophilus infectious disease, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00316680 | Mar → Nov 2006 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, tetanus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06038617 | Oct 2023 → Apr 2025 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02868970 | Feb 2017 → Jul 2021 | — | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00329251 | Apr 2003 → Mar 2006 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03180359 | Jan 2016 → Oct 2019 | disease related to transplantation | Hospices Civils de Lyon | Completed | No outcome recorded |
| — | NCT01611298 | Mar 2008 → Nov 2012 | Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +1 | Robert Krance | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04054752 Comparator | May → Nov 2023 | breast carcinoma, colorectal adenocarcinoma, urinary bladder carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1 | NCT02864368 Background | Dec 2016 → Jun 2020 | glioblastoma | Eric Thompson, M.D. | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03552445 Comparator | Nov 2013 → Apr 2016 | diphtheria, pneumococcal infection, tetanus | Korea University Guro Hospital | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-11-24 | Daiichi Sankyo | "Squarekids® subcutaneous injection syringe", a tetravalent combination vaccine for the prevention of diphtheria, pertussis, tetanus, and poliomyelitis (polio) will be launched daiichisankyo.com ↗ |
| 2014-07-04 | Daiichi Sankyo | Announcement on obtaining in Japan the marketing and manufacturing license for the 4-valent combination vaccine for the prevention of Pertussis, Diphtheria, Tetanus and Poliomyelitis (Polio) “Squarekids® subcutaneous injection syringe” daiichisankyo.com ↗ |
| 2013-02-20 | Daiichi Sankyo | Announcement of application for approval in Japan of DPT-IPV vaccine for prevention of Diphtheria, Pertussis, Tetanus, and acute Poliomyelitis daiichisankyo.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hepatitis B | “Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines” NCT06038617 ↗ |
| Known as | diphtheria, tetanus, pertussis & Hib vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00379977 ↗ |
| Known as | Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00316680 ↗ |
| Known as | GSK2197870A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00871338 ↗ |
| Known as | Polio | “Day 1 Immunization Pre-NT-I7:Td and Polio Day 64, Immunization Post-NT-I7: Hep A#1, Hep B#1 Day 106: Hep B#2 (Optional) 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2,...” NCT04054752 ↗ |
| Known as | Tetanus | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01611298 ↗ |
| Known as | Tetanus-diphtheria | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03552445 ↗ |
| Known as | Tetanus-Diphtheria booster | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02864368 ↗ |
| Modality | Vaccine | “a vaccine” NCT00316680 ↗ |
| Route | Intramuscular | “All vaccines were administered intramuscularly.” NCT00871338 ↗ |