haemophilus influenzae type b conjugate vaccine
Trade name: HibTITER
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
Earliest trial started Jun 1, 1997 (NCT00314041)
Timeline
1980s
1990s
- Jan 1, 1997
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1999
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
2000s
- Feb 4, 2000
Sanofi-Aventis — NDA Secondary Org
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- Aug 19, 2009
GlaxoSmithKline — NDA Secondary Org
Indications
Approved for
Studied for
- Bacterial Infections · Phase 3
- Carrier State · Phase 4
- Communicable Diseases · Phase 2
- Dengue · Phase 3
- Diphtheria · Phase 4
- Diphtheria-Tetanus-acellular Pertussis Vaccines · Phase 1
- Diphtheria-Tetanus-Pertussis Vaccine · Phase 3
- Diphtheria Toxoid · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Dysentery · Phase 2
- Dysentery, Bacillary · Phase 2
- Haemophilus Infections · Phase 4
- Haemophilus influenzae · Phase 4
- Haemophilus influenzae type b · Phase 4
- Healthy Volunteers · Phase 4
- Hepatitis A · Phase 3
- Hepatitis B · Phase 4
- Hospitalization · Phase 4
- Immune System Diseases · Phase 4
- Immunization · Phase 3
- Influenza B virus · Phase 3
- Influenza, Human · Phase 3
- Malaria · Phase 2
- Meninges · Phase 2
- Meningitis · Phase 4
- Meningitis, Bacterial · Phase 3
- Meningitis, Meningococcal · Phase 3
- Meningococcal Infections · Phase 4
- Mortality · Phase 4
- Neisseria meningitidis · Phase 3
- Pertussis Vaccine · Phase 4
- Pneumococcal Infections · Phase 3
- Pneumococcal Vaccines · Phase 3
- Pneumonia, Pneumococcal · Phase 1/Phase 2
- Pneumonia, Staphylococcal · Phase 3
- Poliomyelitis · Phase 4
- Poliovirus Vaccines · Phase 2
- Rotavirus Infections · Phase 3
- Rotavirus Vaccines · Phase 3
- Severe Dengue · Phase 3
- Streptococcal Infections · Phase 4
- Streptococcus pneumoniae · Phase 3
- Tetanus · Phase 4
- Typhoid Fever · Phase 2
- Vaccines · Phase 1
- Virus Diseases · Phase 3
- Whooping Cough · Phase 4
- Yellow Fever · Phase 3
Mechanism of action
- Haemophilus influenzaeImmunity, active
Haemophilus influenzae immunity, active
Approval history
- approvedDec 22, 1987
Chemistry & pharmacology
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaHib vaccine ↗
- NCATSLUY6P8763W ↗
- ChEMBLCHEMBL4298071 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07203755 | Phase 1 | Oct 22, 2025 | Government of China, Tianjin Cansino Biotechnology Inc |
| NCT06621654 | Phase 1 | Oct 31, 2024 | Tianjin Cansino Biotechnology Inc |
| NCT06344065 | Phase 3 | Dec 21, 2023 | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| NCT05091619 | Phase 3 | Oct 22, 2021 | Beijing Tiantan Bio Co., Ltd, China National Biotec Group Co., Ltd, Government of China |
| NCT05401305 | Phase 1 | Jan 14, 2020 | St. Petersburg Research Institute of Vaccines and Sera |
| NCT04099303 | Phase 1 | Dec 20, 2019 | Government of China, Tianjin Cansino Biotechnology Inc |
| NCT03893448 | Phase 3 | Jun 19, 2019 | Merck |
| NCT03891758 | Phase 3 | Apr 1, 2019 | Mitsubishi Tanabe, Osaka University |
| NCT04865497 | Phase 2 | Jan 19, 2019 | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| NCT03620162 | Phase 3 | Oct 18, 2018 | Merck |
| NCT03691610 | Phase 3 | Sep 28, 2018 | Sanofi-Aventis |
| NCT03621670 | Phase 3 | Jul 27, 2018 | GlaxoSmithKline |
| NCT03207750 | Phase 3 | Sep 14, 2017 | GlaxoSmithKline |
| NCT02992925 | Phase 3 | Nov 1, 2016 | Mitsubishi Tanabe, Osaka University |
| NCT02482636 | Phase 2 | Aug 1, 2015 | Public Health England, University of London, University of Oxford |
| NCT02409095 | Phase 4 | Jan 1, 2015 | PATH, Serum Institute of India Pvt. Ltd. |
| NCT02139228 | Phase 3 | Nov 1, 2014 | Novartis |
| NCT02274285 | Phase 3 | Oct 1, 2014 | Sanofi |
| NCT02560272 | Phase 3 | Sep 1, 2014 | Beijing Minhai Biotechnology Co., Ltd, Government of China |
| NCT02096263 | Phase 3 | Apr 1, 2014 | GlaxoSmithKline |
Organizations
Research & Development (49)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 58 | 57 | 3 | 1998 |
| Novartis | For profit | 14 | 14 | 4 | 2007 |
| Government of China | Government | 11 | 5 | 4 | 2011 |
| Sanofi | For profit | 11 | 11 | 3 | 2003 |
| Sanofi-Aventis | For profit | 5 | 1 | 2 | 2003 |
| Merck | For profit | 3 | 3 | 1 | 2011 |
| Mitsubishi Tanabe | For profit | 3 | 3 | 2 | 2014 |
| PT Bio Farma | For profit | 3 | 3 | 3 | 2011 |
| Royal Biological Co., LTD | Academic/Hospital | 3 | 0 | 2 | 2011 |
| Tianjin Cansino Biotechnology Inc | For profit | 3 | 3 | 1 | 2019 |
| Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | For profit | 2 | 2 | 2 | 2019 |
| Beijing Minhai Biotechnology Co., Ltd | For profit | 2 | 2 | 1 | 2013 |
| LG | For profit | 2 | 2 | 1 | 2007 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 1 | 2 | 2001 |
| Osaka University | Academic/Hospital | 2 | 0 | 1 | 2016 |
| PATH | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Pfizer | For profit | 2 | 2 | 2 | 1997 |
| Public Health England | Government | 2 | 1 | 2 | 2003 |
| Aarhus University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Alaska Native Tribal Health Consortium | Government | 1 | 0 | 1 | 2001 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Aug 19, 2009 |
| Merck | For profit | NDA2 | Dec 20, 1989 |
| Merck | For profit | NDA | Dec 20, 1989 |
| Sanofi-Aventis | For profit | NDA2 | Feb 4, 2000 |