Drugs / Hib-MenCY-TT
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01978093 | Feb 2014 → Mar 2016 | 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 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hib-MenCY-TT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01978093 ↗ |
| Known as | MenHibrix | “Biological: Hib-MenCY-TT (MenHibrix®)” NCT01978093 ↗ |
| Modality | Vaccine | “Hib-MenCY-TT (MenHibrix®) vaccine” NCT01978093 ↗ |