Drugs / Synflorix
Synflorix
also known as
GSK1024850A · PHiD-CV · 10Pn · 10Pn-PD-DiT · PHiD-CV10 · 10-valent Pneumococcal Conjugate Vaccine (PCV10) · PCV10
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pneumonia 1 milestone | |||||
| Filed | EU (EMA) | Synflorix | pneumonia | 2012-09-17 | “announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix™” gsk.com ↗ “The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Synflorix | — | 2009-03-29 | europa.eu ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02097472 | Apr 2014 → Dec 2015 | streptococcal pneumonia | PATH | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01171989 | Aug → Dec 2010 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00513409 | Aug 2007 → Feb 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 315 trials · 2 met primary | ||||||
| Phase 3 | NCT01746108 | Jun 2013 → Jun 2015 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01641133 | Sep 2012 → Jul 2013 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01443416 | Apr 2012 → Aug 2013 | pneumococcal infection | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT01619462 | Nov 2011 → Apr 2014 | bacterial infectious disease, infectious disease with sepsis, meningitis, otitis media +1 | Papua New Guinea Institute of Medical Research | Unknown | No outcome recorded |
| Phase 3 | NCT01153841 | Feb → Jul 2011 | streptococcal pneumonia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00911144 | Jun 2009 → Jan 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00861380 | May 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00839254 | Feb 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00678301 | Jun 2008 → Nov 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00680914 | Jun 2008 → May 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00547248 | Oct 2007 → May 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00533507 | Sep 2007 → Jun 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00489554 | Jul 2007 → Mar 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00370396 | Sep 2006 → Jun 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00345358 | Sep 2006 → Nov 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01735084 | Mar 2013 → Feb 2019 | otitis media, respiratory tract infectious disorder | Menzies School of Health Research | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT01485406 Comparator | Dec 2011 → Mar 2012 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01616459 Comparator | Jul 2012 → Apr 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01262872 Comparator | Feb 2011 → Mar 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01204658 Comparator | Sep 2010 → Nov 2011 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01110044 Background | Apr 2010 → Aug 2012 | Rotavirus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT03896477 Comparator | Jul 2019 → Dec 2020 | streptococcal pneumonia | PATH | Completed | No outcome recorded |
| Phase 3 | NCT03197376 Comparator | Jun 2017 → Jun 2018 | streptococcal pneumonia | PATH | Completed | Met primary |
| Phase 3 | NCT01345240 Background | Nov 2011 → Jan 2013 | malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01309646 Background | Mar 2011 → Feb 2012 | diphtheria, haemophilus infectious disease, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01144663 Background | Jul 2010 → Jun 2012 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01174849 Comparator | Aug 2011 → Sep 2017 | otitis media | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT02918708 Comparator | ? → Jan 2017 | — | Public Health England | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 10
| 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. |
| 2015-07-27 | 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. |
| 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). |
| 2013-12-05 | GlaxoSmithKline | Regulatory Synflorix™ receives European marketing authorisation for additional pneumonia indication gsk.com ↗
GlaxoSmithKline (GSK) today announced that the European Commission (EC) has granted marketing authorisation for an additional indication for Synflorix™ for the immunisation against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age. |
| 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 11 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Synflorix | “There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age.” NCT01443416 ↗31“Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule” NCT00861380 ↗ “vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine” NCT01204658 ↗ |
| Known as | 10-valent Pneumococcal Conjugate Vaccine (PCV10) | “10-valent Pneumococcal Conjugate Vaccine (PCV10)” NCT02097472 ↗ |
| Known as | 10Pn | “Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule” NCT00861380 ↗1“Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine” NCT00839254 ↗ |
| Known as | 10Pn-PD-DiT | “Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule” NCT00861380 ↗1“Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine” NCT00839254 ↗ |
| Known as | GSK1024850A | “Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule” NCT00861380 ↗3“Pneumococcal conjugate vaccine Synflorix (GSK1024850A)” NCT00839254 ↗ “Pneumococcal vaccine GSK1024850A (Synflorix)” NCT00680914 ↗ “Biological: Synflorix™( GSK1024850A)” NCT01153841 ↗ |
| Known as | PCV10 | “assessed the effectiveness of the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D-conjugated vaccine (PHiD-CV or PCV10) against bacterial...” PMID 27125273 ↗ Apr 2016 |
| Known as | PHiD-CV | “There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age.” NCT01443416 ↗2“we assessed the indirect impact of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against five pneumococcal disease syndromes.” PMID 34986178 ↗ Jan 2022 “the pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV; Synflorix; GlaxoSmithKline; Brentford, UK)” PMID 33516293 ↗ Jan 2021 |
| Known as | PHiD-CV10 | “We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A),...” PMID 33685411 ↗ Mar 20211“we assessed the indirect impact of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against five pneumococcal disease syndromes.” PMID 34986178 ↗ Jan 2022 |
| Modality | Vaccine | “pneumococcal conjugate vaccine” NCT00345358 ↗ |
| Route | Intramuscular | “Intramuscular injection” NCT00489554 ↗ |