Drugs / Prevnar 13
Prevnar 13
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02892812 | Sep → Nov 2016 | pneumococcal infection | LG Life Sciences | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03819049 | Jun 2019 → Jun 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07333352 | Sep 2025 → Jul 2027 expected | pneumococcal infection | Shanghai Reinovax Biologics Co.,LTD | Recruiting | No outcome recorded |
| Phase 2 | NCT05412030 | Jun 2022 → Sep 2025 | streptococcal pneumonia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03376477 | Sep 2019 → Jan 2024 | plasma cell myeloma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03550313 | Jun 2018 → Nov 2020 | pneumococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT01732198 | Mar 2013 → Jan 2014 | infectious disease | Nuron Biotech Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT00505063 | Jul 2007 → Jun 2025 | childhood malignant neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03620162 | Oct 2018 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02225587 | Aug 2014 → Jul 2015 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01340937 | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 45 trials | ||||||
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 4 | NCT02422264 | Jan 2016 → Mar 2018 | diphtheria, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02072525 | Apr 2014 → Jun 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02141009 | Apr → Dec 2014 | streptococcal pneumonia | St. Antonius Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01577771 | Feb 2013 → May 2014 | pneumococcal infection | Agence de Médecine Préventive, France | Completed | No outcome recorded |
| Comparator or background therapy48 trials | ||||||
| Phase 0 | NCT03729778 Comparator | Jan 2017 → Mar 2020 overdue | AIDS | VA Eastern Colorado Health Care System | Active not recruiting | No outcome recorded |
| Phase 0 | NCT02851056 Background | Sep 2016 → Jul 2018 | plasma cell myeloma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT06183216 Comparator | Jan 2024 → Mar 2025 | pneumococcal infection | Sinovac Research and Development Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06698198 Comparator | Dec 2018 → Sep 2019 | idiopathic severe pneumococcemia | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT03642847 Comparator | Aug 2018 → Mar 2019 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03549208 Comparator | Jul 2018 → Apr 2019 | pneumococcal infection | LG Chem | Unknown | No outcome recorded |
| Phase 1 | NCT02716805 Background | Dec 2016 → Feb 2018 | plasma cell myeloma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded |
| Phase 1/2 | NCT02531373 Comparator | Sep 2015 → Apr 2017 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02037984 Comparator | Jan 2014 → Jul 2016 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT04583618 Comparator | Oct 2020 → Aug 2021 | — | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT03467984 Comparator | May → Oct 2018 | pneumococcal infection | LG Chem | Completed | No outcome recorded |
| Phase 2 | NCT03313037 Comparator | Oct 2017 → Dec 2018 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02987972 Comparator | Mar 2017 → Oct 2018 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT02573181 Comparator | Oct 2015 → Jan 2016 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT02547649 Comparator | Oct 2015 → Jan 2016 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01616459 Comparator | Jul 2012 → Apr 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01545375 Background | May 2012 → Jul 2016 | streptococcal infection | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT01513551 Comparator | Mar 2012 → Feb 2013 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01349569 Background | Jan 2012 → Oct 2016 | plasma cell myeloma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT01262872 Comparator | Feb 2011 → Mar 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01215188 Comparator | Oct 2010 → Jul 2012 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT07017777 Comparator | Nov 2025 → Feb 2027 expected | pneumococcal infection | CanSino Biologics Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03921424 Comparator | Nov 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03885934 Comparator | Jun 2019 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03893448 Comparator | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT03950622 Comparator | Jun 2019 → Mar 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03950856 Comparator | Jun 2019 → Apr 2020 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03731182 Comparator | Jan 2019 → Jun 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03692871 Comparator | Dec 2018 → Mar 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03565900 Comparator | Sep 2018 → Nov 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03621670 Background | Jul 2018 → Dec 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03547167 Comparator | Jul 2018 → Jan 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03480802 Comparator | Jul 2018 → Sep 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03480763 Comparator | Jun 2018 → Dec 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02494999 Comparator | Jun 2016 → Dec 2018 | pneumonia | Jiangsu Province Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 3 | NCT02927444 Comparator | Nov 2015 → Oct 2017 | pneumococcal infection | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02201030 Comparator | Sep 2014 → Oct 2016 | pneumococcal infection | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02096263 Background | Apr 2014 → Feb 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01978093 Background | Feb 2014 → Mar 2016 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01702428 Background | Nov 2012 → Nov 2014 | measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01681992 Background | Oct 2012 → Feb 2015 | measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01553279 Background | Mar 2012 → Sep 2013 | meningococcal infection, viral infectious disease | MCM Vaccines B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01337167 Background | Apr 2011 → May 2013 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01000974 Background | Jun 2010 → Nov 2011 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT04978038 Comparator | Aug → Nov 2022 | COVID-19 | Mark Loeb | Unknown | No outcome recorded |
| Phase 4 | NCT03104075 Comparator | Apr 2017 → Dec 2019 | pneumonia | The Jackson Laboratory | Completed | No outcome recorded |
| Phase 4 | NCT02447718 Comparator | Nov 2015 → Mar 2018 | acute lymphoblastic leukemia | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase 4 | NCT02370069 Comparator | Jun 2015 → Aug 2020 | chronic kidney disease | Lakehead University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Shanghai Zerun Biotechnology Co.,Ltd | Regulatory 这款中国版儿童十三价肺炎疫苗，在约旦正式亮相了！ walvax.com ↗
沃森生物的PCV13是合作方引入约旦市场的首款疫苗，成为首个在约旦正式获批上市的中国疫苗产品。 |
| 2025-02-28 | BioNet-Asia Co., Ltd. | Results Infant Responses to Primary Immunization Following Vaccination in Pregnancy With Varying Doses of Recombinant Acellular Pertussis Vaccine Alone or Combined With Tetanus-Diphtheria bionet-asia.com ↗
We now report on safety and antibody responses to childhood vaccination with diphtheria-tetanus-whole cell pertussis (DTwP) and 13-valent pneumococcal conjugate vaccine (PCV13) in these infants until 13 months of age according to pertussis vaccine the mother received in pregnancy. |
| 2024-10-08 | NPO Petrovax | Results Pneumococcal vaccine reduces risk of death from pneumonia in patients with chronic diseases petrovax.com ↗
Studies show that vaccination reduces the all-cause mortality rate by 30% in people over 65 years of age [ 1 ] . |
| 2024-05-07 | NPO Petrovax | Results World Immunization Week-related conferences in Ekaterinburg and Tashkent petrovax.com ↗
In a 10-year (2012-2022) analysis of pneumococcal vaccination efficacy in patients with chronic obstructive pulmonary disease, survival in the Prevenar®13 vaccine group was 20% higher (47% vs. 27%, respectively) than in the control group. |
| 2020-10-20 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine merck.com ↗ |
| 2018-05-22 | Pfizer | Results A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+ pfizer.com ↗
This indicated that PCV13 use in adults aged 65 and older can prevent 73% of CAP caused by PCV13 serotypes. |
| 2016-07-19 | Pfizer | Regulatory Pfizer Receives World Health Organization Prequalification for Multi-Dose Vial Presentation of Prevenar 13® pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 ® * (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). |
| 2016-07-12 | Pfizer | Regulatory Pfizer Receives FDA Approval for Prevnar 13® in Adults Age 18 Through 49 pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). |
| 2015-09-15 | NPO Petrovax | Regulatory Petrovax Pharm officially recognized as a Russian pneumococcal vaccine manufacturer petrovax.com ↗
The Russian Ministry of Health issued an authorization for NPO Petrovax Pharm LLC for a full-cycle manufacturing of 13-valent conjugated pneumococcal vaccine Prevenar ® 13, including preparation of a finished dosage form (formulation), primary packaging (filling into disposable syringes), secondary packaging, and release quality control. |
| 2015-03-18 | Pfizer | Results Results of Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) Published in the New England Journal of Medicine pfizer.com ↗ |
| 2015-03-03 | Pfizer | Regulatory Pfizer Receives European Approval for New Indication for Prevenar 13 for Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the European Commission approved an expanded indication for the use of Prevenar 13 * (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. |
| 2015-01-22 | Pfizer | Regulatory Prevenar 13®* Receives CHMP Positive Opinion For Prevention Of Vaccine-Type Pneumococcal Pneumonia in Adults pfizer.com ↗
The CHMP’s positive opinion will now be reviewed by the European Commission (EC). |
| 2014-08-13 | Merck Sharp & Dohme LLC | Regulatory Merck Statement regarding Role of PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) in Updated ACIP Recommendations for Pneumococcal Vaccination in Adults merck.com ↗
These recommendations call for a two vaccine regimen utilizing a dose of the pneumococcal conjugate vaccine followed by a dose of Merck’s PNEUMOVAX ® 23, at an interval to be determined by the ACIP, in adults 65 years of age and older who have not previously received pneumococcal vaccine. |
| 2012-06-20 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on CDC Advisory Committee on Immunization Practices’ Recommendation for Pneumococcal Vaccination in Immunocompromised Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided the following statement regarding the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP)’s updated recommendation for pneumococcal vaccine as a two vaccine regimen in adults with immunocompromising conditions, functional or anatomic asplenia, cerebral spinal fluid (CSF) leaks or cochlear implants. |
All press releases naming this drug 16 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prevnar13 | “13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine.” NCT02851056 ↗68“Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care.” NCT03104075 ↗ “13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.])” PMID 21150868 ↗ Dec 2010 “A new vaccine, Prevnar13, has superior immunogenicity and has been recently approved for immunization.” NCT02370069 ↗ “Concomitant Prevnar 13 was given to all groups at 2, 4, 6 and 15 months” PMID 27846058 ↗ Feb 2017 “received a 3-dose primary vaccination course of Prevnar13™ vaccine” NCT01616459 ↗ “Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)” NCT03950622 ↗ “or Prevnar13 in Healthy Adults” NCT02892812 ↗ “Prevnar 13 #1” NCT00505063 ↗ |
| Known as | 13-Valent Pneumococcal Conjugate Vaccine | “13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine.” NCT02851056 ↗1“The 13-valent pneumococcal conjugate vaccine (PCV13) has superior immunogenicity in some categories of immunocompromised adults” PMID 31718534 ↗ Nov 2019 |
| Known as | 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine | “13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)” NCT07333352 ↗ |
| Known as | PCV13 | “13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.])” PMID 21150868 ↗ Dec 20103“A total of 103 children aged 5 to 17 years with SCD were randomized and received a single dose of V114 or Prevnar 13 (PCV13).” PMID 36383730 ↗ Feb 2023 “Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.” NCT03621670 ↗ “V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13)” PMID 36522265 ↗ Dec 2022 |
| Modality | Vaccine | “vaccine, Prevnar 13” NCT00505063 ↗ |
| Route | Intramuscular | “The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid.” NCT01000974 ↗ |