Drugs / Synflorix
Synflorix
also known as
PCV10 · 10-valent pneumococcal conjugate vaccine · PHiD-CV · GSK1024850A · 10Pn · 10Pn-PD-DiT · PHiD-CV10 · 10-valent Pneumococcal Conjugate Vaccine (PCV10) · +7 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Synflorix | — | 2009-03-29 | europa.eu ↗ |
Trials 33 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03636906 | Apr 2019 → Jan 2020 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT02097472 | Apr 2014 → Dec 2015 | streptococcal pneumonia | PATH | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02717494 | Mar 2016 → Nov 2018 | congenital human immunodeficiency virus | Westat | Completed | No outcome recorded |
| 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 2 | NCT00307567 | Nov 2005 → Mar 2006 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03098628 | Mar 2017 → Jun 2020 | — | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT01953510 | Sep 2013 → Jan 2016 | — | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT03547271 | Dec 2018 → May 2023 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT02943902 | Jan 2017 → Feb 2019 | meningitis, pneumonia | University of Witwatersrand, South Africa | Completed | No outcome recorded |
| 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 | NCT00891176 | May 2009 → Nov 2012 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00861380 | May 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00839254 | Feb 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | NCT00370227 | Oct 2006 → Mar 2007 | streptococcal 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 3 | NCT00334334 | Jun 2006 → Jul 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00307034 | Jan 2006 → Jan 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00307541 | Oct 2005 → Apr 2006 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03489018 | Mar 2019 → Sep 2022 | pneumococcal infection | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01735084 | Mar 2013 → Feb 2019 | otitis media, respiratory tract infectious disorder | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT01028326 | Jan → Sep 2010 | streptococcal pneumonia | KEMRI-Wellcome Trust Collaborative Research Program | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01485406 Comparator | Dec 2011 → Mar 2012 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT01110044 Background | Apr 2010 → Aug 2012 | Rotavirus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 37 trials | ||||||
| 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 | No outcome recorded |
| 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 3 | NCT00624819 Background | Mar → Jun 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00370318 Background | Sep 2006 → Apr 2007 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT02961231 Comparator | Oct 2016 → Nov 2020 | streptococcal pneumonia | Nagasaki University | Completed | No outcome recorded |
| Phase 4 | NCT02385513 Comparator | Aug 2015 → Jan 2017 | pneumococcal infection | University of Oxford | 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 |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 55 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 | “Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine” NCT00370227 ↗5“10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib” NCT00307567 ↗ “GSK Biologicals' 10-valent pneumococcal conjugate vaccine” NCT00307541 ↗ |
| Known as | 10-valent Pneumococcal Conjugate Vaccine (PCV10) | “10-valent Pneumococcal Conjugate Vaccine (PCV10)” NCT02097472 ↗ |
| Known as | 10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine | “a pneumococcal conjugate vaccine (10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine [PHiD-CV] or 7-valent cross-reacting material 197 [CRM197]...” PMID 27145999 ↗ Jul 2016 |
| 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 | GSK's pneumococcal polysaccharide conjugate vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03636906 ↗ |
| Known as | GSK1024805A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00624819 ↗ |
| 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 20168“Nepalese infants receive ten-valent pneumococcal conjugate vaccine (PCV10) with a 1 month interval between priming doses for programmatic reasons.” PMID 30635252 ↗ Jan 2019 “Therefore the investigators decided to use PCV10 for the study.” NCT02961231 ↗ “a 0+1 schedule of PCV10 at 12 months of age (Group V)” NCT03098628 ↗ |
| Known as | PHiD-CV | “a pneumococcal conjugate vaccine (10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine [PHiD-CV] or 7-valent cross-reacting material 197 [CRM197]...” PMID 27145999 ↗ Jul 20164“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 ↗ “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 “10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)” PMID 26083474 ↗ Jun 2015 |
| 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 |
| Known as | pneumococcal conjugate vaccine | “This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine” NCT00370227 ↗ |
| Known as | Pneumococcal conjugate vaccine GSK1024850A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00891176 ↗ |
| Known as | Pneumococcal vaccine (10-valent) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03547271 ↗ |
| Known as | Synflorix (PCV10) | “Synflorix (PCV10)” NCT02943902 ↗ |
| Modality | Vaccine | “10-valent pneumococcal conjugate vaccine” NCT00307034 ↗ |
| Route | Intramuscular | “Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).” NCT00307034 ↗ |