Drugs / Pneumococcal
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00307554 | Nov 2005 → Jun 2006 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06038617 | Oct 2023 → Apr 2025 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00329251 | Apr 2003 → Mar 2006 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 0 | NCT01967238 Comparator | Mar 2013 → Mar 2023 | — | Rockefeller University | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2017-10-18 | GlaxoSmithKline | Regulatory GSK receives World Health Organization Prequalification for Synflorix pneumococcal vaccine four-dose vial gsk.com ↗
the World Health Organization (WHO) has awarded prequalification for the new four-dose vial presentation of Synflorix pneumococcal vaccine |
| 2017-06-27 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion for Synflorix pneumococcal vaccine four-dose vial gsk.com ↗
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a new four-dose vial presentation of its Synflorix pneumococcal vaccine. |
| 2015-03-26 | GlaxoSmithKline | Regulatory GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD gsk.com ↗
Synflorix™, a pneumococcal conjugate paediatric vaccine, was also approved today by the MHLW, with an indication for the prevention of invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). |
| 2013-10-25 | GlaxoSmithKline | Regulatory Synflorix™ receives positive opinion from the CHMP in Europe for additional pneumonia indication gsk.com ↗
the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an additional indication for Synflorix™ |
| 2012-09-17 | GlaxoSmithKline | Regulatory Regulatory Update: GSK announces submission for a new indication for Synflorix™ in Europe gsk.com ↗
GlaxoSmithKline plc (GSK) announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix™, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age. |
| 2009-11-05 | GlaxoSmithKline | Regulatory World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine gsk.com ↗
The World Health Organization (WHO) has awarded prequalification for global use of Synflorix™ , GlaxoSmithKline Biologicals’ pneumococcal conjugate vaccine. |
| 2009-03-31 | GlaxoSmithKline | Regulatory Synflorix™, GlaxoSmithKline’s pneumococcal vaccine, receives European authorisation gsk.com ↗
GlaxoSmithKline (GSK) today received European Commission authorisation for Synflorix™, a paediatric pneumococcal vaccine to protect against life-threatening diseases such as meningitis and bacteraemic pneumonia, as well as middle ear infections. |
| 2009-01-21 | GlaxoSmithKline | Regulatory GSK’s paediatric pneumococcal candidate vaccine Synflorix™ receives positive opinion in Europe gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP)has issued a positive opinion and recommends approval of GSK’s paediatric pneumococcal candidate vaccine Synflorix™. |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pneumococcal | “Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines” NCT06038617 ↗ |
| Modality | Vaccine | “10-valent pneumococcal conjugate vaccine” NCT00307554 ↗ |
| Route | Intramuscular | “IM Pneumococcal, meningococcal, or flu vaccine” NCT01967238 ↗ |