Prevenar 13
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Prevenar 13 | — | 2009-12-09 | europa.eu ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07286370 | Apr 2026 → Apr 2028 expected | salmonellosis | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT03873727 | Aug 2019 → May 2022 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02255227 | Apr 2015 → Aug 2019 | inflammatory bowel disease, pneumococcal infection | University Hospital of Saint-Etienne | Terminated | No outcome recorded |
| Phase 2 | NCT02052154 | Mar 2014 → Jul 2016 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02274415 | Sep 2013 → Sep 2017 | pneumococcal infection, sickle cell disease | Assistance Publique - Hôpitaux de Paris | Completed | Met primary |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT06608199 | Nov 2024 → Jun 2025 overdue | pneumococcal infection | Beijing Minhai Biotechnology Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT03439657 | Apr 2018 → May 2019 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02628886 | Mar 2016 → Feb 2019 | pneumonia | London School of Hygiene and Tropical Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT01939158 | Oct 2013 → Dec 2019 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01942174 | Sep 2013 → Aug 2018 | rheumatoid arthritis | University Hospital, Montpellier | Completed | Met primary |
| Phase 3 | NCT01892618 | Aug 2013 → Dec 2015 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Karolinska University Hospital | 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 | NCT01432158 | Jan → Aug 2012 | pneumococcal infection | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT02123433 | Dec 2011 → Oct 2013 | HIV infectious disease, pneumococcal infection | University of Siena | 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 47 trials · 1 met primary | ||||||
| Phase 4 | NCT04460235 | Sep 2021 → Jun 2028 expected | non-Hodgkin lymphoma, pneumococcal infection | Poitiers University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04875819 | Apr 2021 → Dec 2026 expected | HIV infectious disease, meningococcal infection, pneumococcal infection | Thomas Benfield | Recruiting | No outcome recorded |
| Phase 4 | NCT01926860 | Aug 2013 → Oct 2019 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01939522 | Aug 2013 → Apr 2016 | type 1 diabetes mellitus | University of Oxford | 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 | NCT01781871 | Jan 2013 → Oct 2017 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02787863 | Sep 2012 → Dec 2016 | asthma, chronic obstructive pulmonary disease, pneumococcal infection | Mikhael Petrovich Kostinov | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06202703 | Apr 2023 → Oct 2024 | — | Leiden University Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy35 trials | ||||||
| Phase 1 | NCT06550830 Comparator | Sep 2024 → Jun 2025 | pneumococcal infection | Sinovac Life Sciences Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05667740 Comparator | Jan → Oct 2023 | pneumococcal infection | GPN Vaccines | Completed | No outcome recorded |
| Phase 1 | NCT04830358 Comparator | May → Aug 2020 | pneumococcal infection | EuBiologics Co.,Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT05982314 Comparator | Jul 2023 → Aug 2024 | pneumococcal infection | GPN Vaccines | Completed | No outcome recorded |
| Phase 1/2 | NCT02308540 Comparator | Jan 2015 → Apr 2016 | pneumococcal infection | PATH | Completed | No outcome recorded |
| Phase 2 | NCT02279589 Comparator | Dec 2014 → Jun 2016 | pneumococcal infection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01847781 Comparator | May → Nov 2013 | selective IgG immunodeficiency | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01453998 Background | Oct 2011 → Nov 2012 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01248884 Background | Dec 2010 → Jan 2012 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01204658 Comparator | Sep 2010 → Nov 2011 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01090453 Background | May 2010 → Oct 2011 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, meningococcal infection +2 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT07593924 Comparator | May 2026 → Jul 2027 expected | pneumococcal infection | Sinovac Life Sciences Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05759520 Comparator | Nov 2022 → Jun 2025 overdue | pneumococcal infection | Fosun Adgenvax Biopharmaceutical Co.,Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04031846 Comparator | Sep 2019 → Aug 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT04016714 Comparator | Aug 2019 → Oct 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03896477 Comparator | Jul 2019 → Dec 2020 | streptococcal pneumonia | PATH | Completed | No outcome recorded |
| Phase 3 | NCT03207750 Background | Sep 2017 → Oct 2018 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02640703 Comparator | Mar 2015 → Dec 2016 | — | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 3 | NCT02173704 Comparator | Sep 2014 → Dec 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01839188 Background | May 2013 → Mar 2014 | meningococcal infection, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01839175 Background | Apr 2013 → Jul 2014 | meningococcal infection, viral infectious disease | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT01480258 Background | Nov 2011 → Oct 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01439360 Comparator | Oct 2011 → Oct 2014 | influenza | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01341639 Background | May 2011 → Mar 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01218451 Background | Sep 2010 → Jan 2012 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT03565159 Comparator | Aug 2018 → Aug 2023 | infectious disease with sepsis | Guy's and St Thomas' NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT03838497 Comparator | Apr 2015 → Jan 2017 | HIV infectious disease, streptococcal pneumonia | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02215863 Comparator | Sep 2014 → Mar 2015 | influenza, pneumococcal infection | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02002156 Background | Jun 2014 → Aug 2016 | tuberculosis | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT03095326 Background | Sep 2013 → Feb 2014 | pneumococcal infection, thalassemia | Faculty of Medicine, University of Indonesia | Completed | No outcome recorded |
| Phase 4 | NCT01947010 Comparator | Jul 2013 → Aug 2014 | Crohn disease | Statens Serum Institut | Completed | No outcome recorded |
| Phase 4 | NCT02582047 Comparator | Oct → Dec 2012 | influenza, pneumococcal infection | Korea University Guro Hospital | 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 |
| — | NCT02547493 Comparator | Mar 2016 → Jan 2021 | rheumatoid arthritis | University Hospital, Montpellier | Completed | No outcome recorded |
Press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prevenar13 | “New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of...” NCT02255227 ↗62“The purpose of this trial is to investigate in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate vaccine, compared to Pneumovax-II, a...” NCT01432158 ↗ “Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to...” NCT01443416 ↗ “One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.” NCT04875819 ↗ “Prevenar 13 is administered in two doses,each of 0.5 ml, with an interval of 2 months, injected intramuscularly in the deltoid muscle of the arm.” NCT02123433 ↗ “Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.” NCT02173704 ↗ “the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13).” NCT01939522 ↗ “Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.” NCT02547493 ↗ “Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age” NCT01218451 ↗ “Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0” NCT01926860 ↗ “by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis” NCT01942174 ↗ |
| Known as | 13-valent pneumococcal conjugate vaccine | “Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine...” PMID 27919632 ↗ Dec 20162“13-valent pneumococcal conjugate vaccine [Prevenar13®] plus tetanus toxoid” NCT02628886 ↗ “13-valent Pneumococcal Conjugate Vaccine (Prevenar13®)” NCT01781871 ↗ |
| Known as | pCV13 | “Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine...” PMID 27919632 ↗ Dec 20166“Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to...” NCT01443416 ↗ “They received an injection of 13-valent conjugate vaccine (PCV13), followed by an injection of 23-valent polysaccharide vaccine (PPV23) at least 2 months later.” NCT04460235 ↗ “the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13).” NCT01939522 ↗ “Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age” PMID 27846055 ↗ Feb 2017 “single dose 13-valent conjugate pneumococcal vaccine (PCV-13)” NCT03565159 ↗ “Prevenar13 (PCV13) and Pneumovax (PPS23)” NCT03873727 ↗ |
| Known as | Prevenar---13, Pfizer Ltd. | “Prevenar---13®, Pfizer Ltd.” NCT02002156 ↗ |
| Known as | Prevnar 13 | “vaccine with pneumococcal polysaccharides of 13 different serotypes conjugated to a protein (Prevnar13)” NCT06202703 ↗1“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age” PMID 27846055 ↗ Feb 2017 |
| Modality | Vaccine | “Prevenar 13® vaccines” NCT01090453 ↗ |
| Route | Intramuscular | “The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly” NCT01090453 ↗ |