haemophilus influenzae type b conjugate vaccine

Trade name: HibTITER

Vaccineapproved

Approved

Dec 22, 1987

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis. — Wikipedia

Clinical trial activity

124 trials · 49 clinical orgs · 3 marketing orgs

Phase 1
10
Phase 2
103
Phase 3
75
Phase 4
12

Earliest trial started Jun 1, 1997 (NCT00314041)

Timeline

1980s

  1. Dec 22, 1987

    Earliest FDA Approval

  2. Dec 20, 1989

    Merck — First NDA Organization

  3. Dec 20, 1989

    Merck — NDA Secondary Org

  4. Dec 20, 1989

    Merck — NDA Organization

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1999

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

2000s

  1. Feb 4, 2000

    Sanofi-Aventis — NDA Secondary Org

  2. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  3. Aug 19, 2009

    GlaxoSmithKline — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedDec 22, 1987

Chemistry & pharmacology

Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • a+c+hib conjugate vaccine
  • acthib
  • acthib
  • acthib
  • act-hib
  • combact-hib
  • dpo 20 vaccine
  • gsk208108
  • haemophilus b conjugate vaccine
  • haemophilus b conjugate vaccine (meningococcal protein conjugate)
  • haemophilus b conjugate vaccine (tetanus toxoid conjugate)
  • haemophilus influenzae b oligosaccharide vaccine-diphtheria toxoid conjugate
  • haemophilus influenzae type b conjugate vaccine
  • haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate
  • haemophilus influenzae type b vaccine
  • haemophilus influenzae type b vaccine, pure polysaccharide
  • haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
  • hib capsular polysaccharide-tetanus vaccine
  • hib conjugate vaccine
  • hib cps-tetanus vaccine
  • hib-crm197
  • hiberix
  • hibest
  • hib-ps-diphtheria toxoid conjugate vaccine
  • hib-ps-dt vaccine
  • hib-tt
  • hib-tt
  • hib vaccine
  • hib-vax
  • infanrix-ipv/hib
  • lbvh0101
  • minhai-hib
  • omnihib
  • omnihib
  • prohibit
  • prohibit
  • prp antigen
  • prp-d
  • prp-t
  • tetanus toxoid polysaccharide-conjugated vaccine against haemophilus influenzae type b
  • type b haemophilus influenza conjugate vaccine
  • vaxem hib
  • zilbrix

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07203755Phase 1Oct 22, 2025Government of China, Tianjin Cansino Biotechnology Inc
NCT06621654Phase 1Oct 31, 2024Tianjin Cansino Biotechnology Inc
NCT06344065Phase 3Dec 21, 2023Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT05091619Phase 3Oct 22, 2021Beijing Tiantan Bio Co., Ltd, China National Biotec Group Co., Ltd, Government of China
NCT05401305Phase 1Jan 14, 2020St. Petersburg Research Institute of Vaccines and Sera
NCT04099303Phase 1Dec 20, 2019Government of China, Tianjin Cansino Biotechnology Inc
NCT03893448Phase 3Jun 19, 2019Merck
NCT03891758Phase 3Apr 1, 2019Mitsubishi Tanabe, Osaka University
NCT04865497Phase 2Jan 19, 2019Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT03620162Phase 3Oct 18, 2018Merck
NCT03691610Phase 3Sep 28, 2018Sanofi-Aventis
NCT03621670Phase 3Jul 27, 2018GlaxoSmithKline
NCT03207750Phase 3Sep 14, 2017GlaxoSmithKline
NCT02992925Phase 3Nov 1, 2016Mitsubishi Tanabe, Osaka University
NCT02482636Phase 2Aug 1, 2015Public Health England, University of London, University of Oxford
NCT02409095Phase 4Jan 1, 2015PATH, Serum Institute of India Pvt. Ltd.
NCT02139228Phase 3Nov 1, 2014Novartis
NCT02274285Phase 3Oct 1, 2014Sanofi
NCT02560272Phase 3Sep 1, 2014Beijing Minhai Biotechnology Co., Ltd, Government of China
NCT02096263Phase 3Apr 1, 2014GlaxoSmithKline
Showing 20 of 124 trials
Page 1 / 7

Organizations

Research & Development (49)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit585731998
NovartisFor profit141442007
Government of ChinaGovernment11542011
SanofiFor profit111132003
Sanofi-AventisFor profit5122003
MerckFor profit3312011
Mitsubishi TanabeFor profit3322014
PT Bio FarmaFor profit3332011
Royal Biological Co., LTDAcademic/Hospital3022011
Tianjin Cansino Biotechnology IncFor profit3312019
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.For profit2222019
Beijing Minhai Biotechnology Co., LtdFor profit2212013
LGFor profit2212007
National Institute of Allergy and Infectious Diseases (NIAID)Government2122001
Osaka UniversityAcademic/Hospital2012016
PATHAcademic/Hospital2122014
PfizerFor profit2221997
Public Health EnglandGovernment2122003
Aarhus UniversityAcademic/Hospital1012005
Alaska Native Tribal Health ConsortiumGovernment1012001
49 organizations
Page 1 / 3

Marketing (4)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDA2Aug 19, 2009
MerckFor profitNDA2Dec 20, 1989
MerckFor profitNDADec 20, 1989
Sanofi-AventisFor profitNDA2Feb 4, 2000