15-valent pneumococcal conjugate vaccine

Trade name: VAXNEUVANCE

VaccineapprovedBreakthrough Therapy FDA

Approved

Jul 16, 2021

Clinical trial activity

44 trials · 10 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
36
Phase 3
29
Phase 4
2

Earliest trial started Sep 1, 2009 (NCT01215175)

Timeline

2000s

  1. Jan 1, 2009

    Merck — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Merck — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2018

    Merck — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jul 16, 2021

    Merck — Earliest FDA Approval

  2. Jul 16, 2021

    Merck — NDA Secondary Org

  3. Jul 16, 2021

    Merck — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedBreakthroughJul 16, 2021

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Also known as

  • v114
  • v114

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06975878Phase 3May 22, 2025Sanofi
NCT06855160Phase 3Apr 17, 2025GlaxoSmithKline
NCT06806137Phase 3Mar 5, 2025GlaxoSmithKline
NCT06731374Phase 4Jan 31, 2025University of Liverpool, University of Oxford
NCT06740630Phase 3Dec 17, 2024GlaxoSmithKline
NCT06693895Phase 3Nov 19, 2024GlaxoSmithKline
NCT06271681Phase 4May 1, 2024Department of Veteran Affairs, Merck
NCT05939219N/AJul 1, 2023Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT05696080Phase 3Feb 13, 2023Merck
NCT05489328Phase 1Aug 15, 2022Pfizer
NCT05393037Phase 3Jul 13, 2022Merck
NCT05420961Phase 3Jul 12, 2022Merck
NCT05158140Phase 3Jan 12, 2022Merck
NCT06817187Phase 3Sep 16, 2021Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT04633226Phase 3Jan 7, 2021Merck
NCT04357522Phase 3Jul 31, 2020Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT04193215Phase 3Jun 17, 2020Merck
NCT04384107Phase 3Jun 9, 2020Merck
NCT04830358Phase 1May 28, 2020EuBiologics Co.,Ltd
NCT03921424Phase 3Sep 30, 2019Merck
Showing 20 of 44 trials
Page 1 / 3

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit323142009
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.For profit4432019
GlaxoSmithKlineFor profit4412024
Department of Veteran AffairsGovernment1112024
EuBiologics Co.,LtdFor profit1112020
Government of ChinaGovernment1012019
PfizerFor profit1112022
SanofiFor profit1112025
University of LiverpoolAcademic/Hospital1012025
University of OxfordAcademic/Hospital1112025
10 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
MerckFor profitNDA2Jul 16, 2021
MerckFor profitNDAJul 16, 2021