Drugs / Prevenar
Prevenar
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Prevenar | — | 2017-11-21 | europa.eu ↗ |
| Approved | EU (EMA) | Prevenar | — | 2001-02-02 | europa.eu ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00900978 | May 2009 → Aug 2010 | pneumococcal infection | German-Jordanian University | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00219401 | May 2005 → May 2009 | meningitis, otitis media, pneumonia | Papua New Guinea Institute of Medical Research | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00611663 | May 2008 → Dec 2014 | systemic lupus erythematosus | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT04214444 | Jul 2020 → May 2024 | diffuse large B-cell lymphoma, pneumococcal infection | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT01444781 | Sep 2011 → Apr 2013 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis +1 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00999739 | Dec 2007 → Apr 2008 | HIV infectious disease | Hospital Universitari Son Dureta | Unknown | Missed primary |
| Phase 3 | NCT00333450 | Aug → Dec 2006 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00656409 | Jun 2006 → Mar 2008 | ataxia telangiectasia | Institute of Child Health | Completed | No outcome recorded |
| Phase 3 | NCT00169728 | Sep 2003 → Jun 2006 | disease related to hematopoietic stem cell transplant | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT01193582 | Sep 2010 → Sep 2012 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00828997 | Aug 2008 → Jan 2018 | rheumatoid arthritis, spondyloarthropathy | Region Skane | Completed | No outcome recorded |
| Phase 4 | NCT00581035 | Jan 2006 → May 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00276107 | Dec 2004 → Dec 2005 | pneumococcal infection | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00843895 | Mar → Aug 2009 | pneumococcal infection | King Saud University | Unknown | No outcome recorded |
| Comparator or background therapy25 trials | ||||||
| Phase 1/2 | NCT00562939 Comparator | Jan 2008 → Jan 2009 | HIV infectious disease | University of Aarhus | Completed | Met primary |
| Phase 2 | NCT01414504 Comparator | Dec 2009 → Sep 2011 | — | William Pomat | Completed | No outcome recorded |
| Phase 2 | NCT01003418 Background | Nov 2009 → Nov 2010 | influenza | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00871338 Background | Jun 2009 → Mar 2010 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00679159 Comparator | Feb 2008 → Dec 2009 | tuberculosis | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT00134719 Background | Apr 2005 → Jul 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00127855 Background | Mar 2003 → Feb 2004 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01983540 Background | Oct 2013 → Jun 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00907777 Comparator | Jun → Oct 2009 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00911144 Comparator | Jun 2009 → Jan 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00680914 Comparator | Jun 2008 → May 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00652951 Comparator | Apr 2008 → May 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00624819 Background | Mar → Jun 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00657709 Comparator | Mar 2008 → Jan 2010 | meningococcal meningitis | Novartis Vaccines | Completed | Met primary |
| Phase 3 | NCT00586612 Background | Dec 2007 → Dec 2008 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00547248 Comparator | Oct 2007 → May 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00463437 Comparator | Apr 2007 → Jan 2008 | diphtheria, hepatitis B virus infection, pneumococcal infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00370396 Comparator | Sep 2006 → Jun 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00344318 Comparator | Aug 2006 → Apr 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00343421 Background | Jul 2006 → Jun 2008 | diphtheria, haemophilus infectious disease, pertussis, poliomyelitis +1 | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 4 | NCT00836641 Comparator | Oct 2006 → Oct 2008 | asthma | Johann Wolfgang Goethe University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00294294 Background | May 2005 → Dec 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00581620 Comparator | Nov 2002 → Sep 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| — | NCT02240888 Comparator | Oct 2011 → Dec 2017 | Sjogren syndrome, rheumatoid arthritis, scleroderma, systemic lupus erythematosus +1 | Region Skane | Completed | No outcome recorded |
| — | NCT01263210 Comparator | Mar 2003 → Jun 2009 | otitis media | Lund University Hospital | Completed | No outcome recorded |
Press releases naming this drug 8 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prevenar | “Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the...” NCT00333450 ↗38“Day 0: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 90: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 270: 0.5 ml Pneumo Novum + 1 mg CpG 7909, IM” NCT00562939 ↗ “To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.” NCT00581620 ↗ “a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®)” NCT04214444 ↗ “To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.” NCT01444781 ↗ |
| Known as | 7 valent pneumococcal conjugate vaccine | “7 valent pneumococcal conjugate vaccine (7v-PCV) - Prevenar” NCT00900978 ↗ |
| Known as | 7v-PCV | “7 valent pneumococcal conjugate vaccine (7v-PCV) - Prevenar” NCT00900978 ↗ |
| Known as | PCV7 | “heptavalent pneumococcal conjugate vaccine (Prevenar 7; PCV7) and non-vaccinated individually matched arthritis patients.” PMID 25656734 ↗ Feb 20151“Prevenar (PCV7)” NCT01983540 ↗ |
| Known as | Pneumococcal 7 valent conjugate vaccine | “Pneumococcal 7 valent conjugate vaccine (Prevenar®)” NCT00219401 ↗ |
| Known as | Prevenar (heptavalent conjugated pneumococcal vaccine) | “Prevenar (heptavalent conjugated pneumococcal vaccine)” NCT00999739 ↗ |
| Known as | Prevenar 7 | “heptavalent pneumococcal conjugate vaccine (Prevenar 7; PCV7) and non-vaccinated individually matched arthritis patients.” PMID 25656734 ↗ Feb 2015 |
| Known as | Prevenar13 | “13-valent pneumococcal conjugate vaccine (Prevenar13)” PMID 28081972 ↗ Jan 2017 |
| Modality | Vaccine | “3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines” NCT00134719 ↗ |
| Route | Intramuscular | “Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.” NCT00127855 ↗ |