pneumococcal 13-valent conjugate vaccine

Trade name: prevnar 13

Vaccineapproved

Approved

Feb 24, 2010

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children. — Wikipedia

Clinical trial activity

336 trials · 166 clinical orgs · 1 marketing orgs

Phase 1
48
Phase 2
214
Phase 3
128
Phase 4
71

Earliest trial started Nov 1, 2000 (NCT00729001)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Feb 24, 2010

    Pfizer — Earliest FDA Approval

  2. Feb 24, 2010

    Pfizer — NDA Secondary Org

  3. Feb 24, 2010

    Pfizer — NDA Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedFeb 24, 2010

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 13-valent pneumococcal vaccine
  • bk-um peptide
  • corynebacterium diphtheriae crm197 protein
  • crm197
  • crm197
  • crm 197
  • crm-197
  • crm-197
  • crm197 (non-toxic variant of diphtheria toxin)
  • crm(197) of diphtheria toxin
  • cross reacting material 197
  • cross reacting material (crm(197)) of diphtheria toxin
  • diptheria crm197 protein
  • diptheria toxin mutant crm19
  • nbp606
  • pcv13
  • pcv-13
  • pcv13a
  • pcv13a vaccine
  • pcv-13 vaccine
  • pcv13 vaccine
  • pneumo-bacterin
  • pneumococcal 13-valent conjugate vaccine
  • pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)
  • pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein)
  • pneumococcal polysaccharide serotype 1 /pneumococcal polysaccharide serotype 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f /pneumococcal polysaccharide serotype 14 /pneumococcal polysaccharide serotype 18c /pneumococcal polysaccharide serotype 19f / pneumococcal polysaccharide serotype 23f /pneumococcal polysaccharide serotype 4 /pneumococcal polysaccharide serotype 5 /pneumococcal polysaccharide serotype 6b /pneumococcal polysaccharide serotype 7f /pneumococcal polysaccharide serotype 9v
  • pneumococcal polysaccharide serotype 1 /pneumococcal polysaccharide serotype 14 /pneumococcal polysaccharide serotype 18c /pneumococcal polysaccharide serotype 19a / pneumococcal polysaccharide serotype 19f /pneumococcal polysaccharide serotype 23f /pneumococcal polysaccharide serotype 3 /pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 5 / pneumococcal polysaccharide serotype 6a / pneumococcal polysaccharide serotype 6b /pneumococcal polysaccharide serotype 7f /pneumococcal polysaccharide serotype 9v protein
  • pneumococcal polysaccharide serotype 4 /pneumococcal polysaccharide serotype 6b /pneumococcal polysaccharide serotype 9v /pneumococcal polysaccharide serotype 14 / pneumococcal oligosaccharide serotype 18c /pneumococcal polysaccharide serotype 19f /pneumococcal polysaccharide serotype 23f
  • pneumococcal vaccine
  • pneumococcal vaccine
  • prevenar
  • prevenar13
  • prevenar13
  • prevenar 13
  • prevenar 13
  • prevnar
  • prevnar
  • prevnar13
  • prevnar 13
  • prevnar 13
  • prevnar 13
  • primeboost conjugated anti- pneumococcal vaccine
  • vi-crm197

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07252791Phase 4Jan 1, 2026Insituto Adolfo Lutz, University of Sao Paulo
NCT07242092Phase 4Jan 1, 2026Insituto Adolfo Lutz, University of Sao Paulo
NCT07135453Phase 4Dec 31, 2025Merck, University of Alabama, Birmingham
NCT07286370Phase 2Dec 17, 2025GlaxoSmithKline
NCT07284654Phase 3Dec 1, 2025Vaxcyte, Inc.
NCT07205289Phase 1Oct 31, 2025GPN Vaccines
NCT07017777Phase 3Oct 15, 2025Tianjin Cansino Biotechnology Inc
NCT07019909Phase 1Jul 6, 2025Pfizer
NCT06986239Phase 1Jul 1, 2025LiteVax BV
NCT07023081Phase 1Jun 15, 2025Pfizer
NCT06970756Phase 1May 27, 2025Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT06817421Phase 4Apr 30, 2025Menzies School of Health Research, Murdoch University, University of Edinburgh, University of Western Australia
NCT06855160Phase 3Apr 17, 2025GlaxoSmithKline
NCT06806137Phase 3Mar 5, 2025GlaxoSmithKline
NCT06740630Phase 3Dec 17, 2024GlaxoSmithKline
NCT06693895Phase 3Nov 19, 2024GlaxoSmithKline
NCT06647407Phase 1/Phase 2 (Phase 2)Oct 28, 2024Sanofi-Aventis
NCT06617715Phase 3Oct 12, 2024China National Pharmaceutical Group, Government of China
NCT06550830Phase 1Aug 28, 2024China National Pharmaceutical Group, Government of China
NCT06703203Phase 1/Phase 2 (Phase 2)Aug 27, 2024Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Showing 20 of 336 trials
Page 1 / 17

Organizations

Research & Development (166)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit575532000
SanofiFor profit383642002
PfizerFor profit373052002
MerckFor profit312742006
Sanofi-AventisFor profit271642007
NovartisFor profit151442004
University of LondonAcademic/Hospital9332006
Government of ChinaGovernment7122020
University of ParisAcademic/Hospital7522008
WyethFor profit7032002
National Cancer Institute (NCI)Government6132011
Murdoch UniversityAcademic/Hospital5022013
National Institute of Allergy and Infectious Diseases (NIAID)Government5222005
University of OxfordAcademic/Hospital5532008
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.For profit4442020
Korea UniversityAcademic/Hospital4412012
Mayo ClinicAcademic/Hospital4432015
Menzies School of Health ResearchAcademic/Hospital4422011
PATHAcademic/Hospital4222011
AffinivaxFor profit3122019
166 organizations
Page 1 / 9

Marketing (2)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDA2Feb 24, 2010
PfizerFor profitNDAFeb 24, 2010