Drugs / Menhibrix
Menhibrix
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00134719 | Apr 2005 → Jul 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00129129 | Aug 2004 → Sep 2005 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT00614614 | Feb 2008 → Jul 2009 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00345683 | Jul 2007 → Sep 2008 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00359983 | Sep 2006 → Nov 2007 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00345579 | Sep 2006 → Oct 2007 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00289783 | Feb 2006 → Aug 2007 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-06-14 | GlaxoSmithKline | Regulatory GSK receives FDA approval for MenHibrix gsk.com ↗
GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved the vaccine MenHibrix® [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine]. |
| 2011-12-01 | GlaxoSmithKline | Regulatory Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine gsk.com ↗
GlaxoSmithKline [NYSE:GSK] today submitted additional information to the U.S. Food and Drug Administration (FDA) in support of the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine MenHibrix® (Hib-MenCY-TT). |
| 2011-09-23 | GlaxoSmithKline | Regulatory Regulatory Update: GlaxoSmithKline receives Complete Response letter from FDA for candidate meningococcal and Hib combination vaccine gsk.com ↗
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix® (Hib-MenCY-TT). |
| 2010-06-10 | GlaxoSmithKline | Regulatory GlaxoSmithKline Receives Complete Response from FDA for Candidate Meningococcal and Hib Combination Vaccine gsk.com ↗
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix® (Hib-MenCY). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2012-06-14 | GlaxoSmithKline | GSK receives FDA approval for MenHibrix gsk.com ↗ |
| 2011-12-01 | GlaxoSmithKline | Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine gsk.com ↗ |
| 2011-09-23 | GlaxoSmithKline | Regulatory Update: GlaxoSmithKline receives Complete Response letter from FDA for candidate meningococcal and Hib combination vaccine gsk.com ↗ |
| 2010-06-10 | GlaxoSmithKline | GlaxoSmithKline Receives Complete Response from FDA for Candidate Meningococcal and Hib Combination Vaccine gsk.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MenHibrix | “Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination...” NCT00345683 ↗6“Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax.” NCT00289783 ↗ “Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4)” NCT00345579 ↗ “received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™” NCT00129129 ↗ |
| Known as | GSK 792014 | “GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)” NCT00614614 ↗ |
| Known as | Hib-MenCY-TT | “Biological: MenHibrix (Hib-MenCY-TT)” NCT00134719 ↗1“MenHibrix (Hib-MenCY-TT)” NCT00359983 ↗ |
| Modality | Vaccine | “Menhibrix vaccine” NCT00345579 ↗ |
| Route | Intramuscular | “Menhibrix™ was administered intramuscularly (IM)” NCT00129129 ↗ |