Drugs / GSK1024850A
GSK1024850A
also known as
Synflorix · SynflorixTM · GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) · GSK Biologicals´ Pneumococcal Conjugate Vaccine · GSK's 10-valent Pneumococcal Vaccine 1024850A · PHiD-CV · Synflorix vaccine
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00985751 | Nov 2009 → Oct 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 319 trials · 2 met primary | ||||||
| Phase 3 | NCT02447432 | Jun 2015 → Jan 2016 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01175083 | Jun 2011 → Jan 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01153893 | Oct 2010 → Feb 2011 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01119625 | Jul 2010 → Feb 2011 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01030822 | Apr 2010 → Aug 2011 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01027845 | Dec 2009 → Aug 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00985465 | Nov 2009 → Jun 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00907777 | Jun → Oct 2009 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00814710 | Mar → Nov 2009 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00829010 | Feb 2009 → Jun 2011 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00808444 | Jan → Nov 2009 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00758264 | Oct 2008 → Jun 2009 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00652951 | Apr 2008 → May 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00609492 | Jan → Nov 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00496015 | Jul 2007 → Mar 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00466947 | Jun 2007 → Aug 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00463437 | Apr 2007 → Jan 2008 | diphtheria, hepatitis B virus infection, pneumococcal infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00390910 | Oct 2006 → Jul 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00344318 | Aug 2006 → Apr 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01235949 | Nov 2010 → Mar 2012 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00970307 Background | Aug 2009 → Jan 2010 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00950833 Comparator | Aug 2009 → Sep 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00792909 Comparator | Dec 2008 → Jul 2009 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| 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 |
| 2015-07-27 | GlaxoSmithKline | Regulatory GSK’s Synflorix™ receives CHMP positive opinion for major label extension 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 the expansion of the SynflorixTM European label. |
| 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™ |
| 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 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GSK 1024850A | “GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine” NCT00970307 ↗24“10-valent pneumococcal vaccine (GSK 1024850A)” NCT00970307 ↗ |
| Known as | GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) | “GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT)” NCT02447432 ↗ |
| Known as | GSK Biologicals´ Pneumococcal Conjugate Vaccine | “GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)” NCT00609492 ↗ |
| Known as | GSK's 10-valent Pneumococcal Vaccine 1024850A | “GSK's 10-valent Pneumococcal Vaccine 1024850A” NCT00463437 ↗ |
| Known as | PHiD-CV | “10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)” PMID 25008901 ↗ Jul 2014 |
| Known as | Synflorix | “clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh” NCT00808444 ↗2“GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)” NCT00652951 ↗ “GSK1024850A (Synflorix)” NCT01175083 ↗ |
| Known as | Synflorix vaccine | “10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A)” NCT00466947 ↗ |
| Known as | SynflorixTM | “Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of...” NCT00814710 ↗1“GSK1024850A (SynflorixTM)” NCT01235949 ↗ |
| Modality | Vaccine | “10-valent Pneumococcal Conjugate Vaccine” NCT00390910 ↗ |
| Route | Intramuscular | “Intramuscular injection, 3 doses” NCT00390910 ↗ |