Drugs / Pneumovax 23
Pneumovax 23
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05163834 | Nov 2021 → Mar 2022 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT02543918 | Sep → Nov 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00479323 | Jun 2007 → Aug 2008 | pneumococcal infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00169234 | May 2003 → Feb 2005 | pneumonia | Kaiser Permanente | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT00307567 | Nov 2005 → Mar 2006 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00170612 | Nov 2005 → Jan 2008 | pneumococcal infection | University of Melbourne | Completed | No outcome recorded |
| Phase 2 | NCT00307008 | Oct 2003 → Feb 2005 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 310 trials · 3 met primary | ||||||
| Phase 3 | NCT03565900 | Sep 2018 → Nov 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03547167 | Jul 2018 → Jan 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03480802 | Jul 2018 → Sep 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03480763 | Jun 2018 → Dec 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02218697 | Oct 2014 → Jan 2015 | influenza | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02225587 | Aug 2014 → Jul 2015 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02045836 | Mar 2014 → Jul 2015 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01734239 | Jun → Oct 2013 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00535730 | Jun 2007 → Feb 2008 | herpes zoster, pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00333450 | Aug → Dec 2006 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 4 | NCT04460235 | Sep 2021 → Jun 2028 expected | non-Hodgkin lymphoma, pneumococcal infection | Poitiers University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04481243 | Apr 2021 → Jan 2023 | type 1 diabetes mellitus | Mayo Clinic | Completed | 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 | NCT02429531 | Oct 2015 → Aug 2018 | immunodeficiency due to selective anti-polysaccharide antibody deficiency | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02260882 | Oct 2014 → Apr 2015 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT02072525 | Apr 2014 → Jun 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 0 | NCT05346302 Comparator | Feb → Dec 2022 | inflammatory disease | Texas A&M University | Completed | No outcome recorded |
| Phase 1 | NCT05667740 Comparator | Jan → Oct 2023 | pneumococcal infection | GPN Vaccines | Completed | No outcome recorded |
| Phase 1 | NCT04665050 Comparator | Feb → Apr 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02097589 Background | Jun → Sep 2014 | — | University of Florida | Completed | Met primary |
| Phase 1/2 | NCT05982314 Comparator | Jul 2023 → Aug 2024 | pneumococcal infection | GPN Vaccines | Completed | No outcome recorded |
| Phase 1/2 | NCT04168190 Comparator | Dec 2019 → Jul 2021 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1/2 | NCT02308540 Comparator | Jan 2015 → Apr 2016 | pneumococcal infection | PATH | Completed | No outcome recorded |
| Phase 2 | NCT04583618 Comparator | Oct 2020 → Aug 2021 | — | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT02232191 Comparator | Dec 2014 → Jul 2026 overdue | — | University of California, Davis | Recruiting | No outcome recorded |
| Phase 2 | NCT01513551 Comparator | Mar 2012 → Feb 2013 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00307528 Comparator | Jan 2004 → Mar 2005 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03921424 Background | Nov 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02285036 Comparator | Sep → Dec 2012 | pneumococcal infection | Walvax Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00785967 Background | Jan 2009 → Aug 2011 | HIV infectious disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 | NCT02582047 Comparator | Oct → Dec 2012 | influenza, pneumococcal infection | Korea University Guro Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-10-01 | MSD R&D (China) Co., Ltd. | Results CAPVAXIVE®（21価肺炎球菌結合型ワクチン）、肺炎球菌感染症の罹患リスクの高い小児および思春期層において良好な免疫応答を示す msd.co.jp ↗
CAPVAXIVE®の免疫応答を接種後30日目における血清型特異的OPA GMTで評価した結果、PPSV23に対し、共通の12種類の血清型については非劣性を、CAPVAXIVE®に固有の9種類の血清型については優越性を示しました（免疫原性の主要評価項目）。 |
| 2025-09-01 | Sinovac Biotech Co., Ltd | Results 国际学术期刊《疫苗》刊文：科兴23价肺炎疫苗具有良好的免疫原性和安全性，与国际同类疫苗相当 sinovac.com ↗
本次研究证实了科兴PPSV23在2岁及以上人群中安全性良好且能诱导显著免疫应答，其免疫效果与国际同类疫苗相当或更优，可作为肺炎球菌免疫的安全有效选择。 |
| 2025-08-14 | Sinovac Biotech Co., Ltd | Results 《免疫学前沿》刊文：科兴四价流感疫苗与23价肺炎疫苗在老年慢病人群中同时接种具有良好的免疫原性和安全性 sinovac.com ↗
这项由江苏省泰州市疾病预防控制中心牵头开展的随机、对照、开放性Ⅳ期临床研究显示，由北京科兴生物制品有限公司生产的 四价流感病毒裂解疫苗(IIV4)和23价肺炎球菌多糖疫苗(PPSV23)在60岁及以上老年慢性疾病人群中单独接种和同时接种的免疫原性均非劣效于健康人群，并具有良好的安全性。 |
| 2024-09-05 | Sinovac Biotech Co., Ltd | Results SINOVAC科兴四价流感疫苗与23价肺炎疫苗在60岁及以上老年人中同时接种具有良好的安全性和免疫原性 sinovac.com ↗
研究结果表明， 四价流感病毒裂解疫苗和23价肺炎球菌多糖疫苗在60岁及以上的老年人群中同时接种的免疫原性非劣效于单独接种，并且具有良好的安全性 。 |
| 2024-07-30 | GlaxoSmithKline | Results GSK presents new data at the Alzheimer's Association International Conference 2024 gsk.com ↗
Retrospective study observed statistically significant association between Shingrix vaccination and reduction of dementia risk, compared to Zostavax and Pneumovax 23, with further studies planned |
| 2024-05-29 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA 成人向けに特化して設計された、開発中の 21価肺炎球菌結合型ワクチンV116の良好なデータを発表 msd.co.jp ↗
V116は、PPSV23と共通する12種類の血清型において、PPSV23に対して免疫応答の非劣性を示しました。 |
| 2024-04-29 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults merck.com ↗
V116 elicited immune responses that were noninferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. |
| 2023-08-11 | Sinovac Biotech Co., Ltd | Results 最新研究：科兴四价流感疫苗与23价肺炎疫苗在60岁及以上老年人中同时接种具有良好的安全性 sinovac.com ↗
这项由江苏泰州疾控中心研究人员开展的研究显示， 北京科兴生物制品有限公司的四价流感病毒裂解疫苗与23价肺炎球菌多糖疫苗在60岁及以上老年人中同时接种具有良好的安全性 [1] 。 |
| 2021-10-20 | Merck Sharp & Dohme LLC | Regulatory CDC ACIP Unanimously Votes to Provisionally Recommend Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Series with PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) as an Option for Pneumococcal Vaccination in Appropriate Adults merck.com ↗
In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or with a single dose of 20-valent pneumococcal conjugate vaccine. |
| 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 ↗
Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. |
| 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 supports today’s ACIP recommendation for the use of PNEUMOVAX 23 as part of the regimen in these individuals, |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pneumovax 23 | “Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the...” NCT00333450 ↗42“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 ↗ “Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care.” NCT03104075 ↗ “23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib;” NCT00307567 ↗ “Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.” NCT02045836 ↗ “Pneumovax 23: 0.5ml IM at screening” NCT00785967 ↗ “GCflu and Pneumovax-23” NCT02582047 ↗ “PNEUMOVAX™ 23” NCT00535730 ↗ |
| Known as | 23-Valent Pneumococcal Polysaccharide Vaccination | “PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)” NCT02260882 ↗ |
| Known as | 23-valent polysaccharide pneumococcal vaccine | “23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib;” NCT00307567 ↗ |
| Known as | Pneumococcal Vaccine, Polyvalent (23-valent) | “Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23” NCT00535730 ↗ |
| Known as | PPV23 | “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 ↗2“PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)” NCT02260882 ↗ “PNEUMOVAX® 23 (pneumococcal vaccine: PPV23)” PMID 20980796 ↗ Nov 2010 |
| Known as | V110 | “PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)” NCT02260882 ↗ |
| Modality | Vaccine | “23-valent pneumococcal polysaccharide vaccine” NCT00170612 ↗ |
| Route | Intramuscular | “Single dose intramuscular injection” NCT00307008 ↗ |