DTaP, inactivated poliovirus, haemophilus influenzae b conjugate, hepatitis b vaccine
Trade name: Pediarix
Vaccineapproved
Approved
Dec 13, 2002
DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B. — Wikipedia
Clinical trial activity
134 trials · 46 clinical orgs · 3 marketing orgs
Phase 1
6
Phase 2
103
Phase 3
74
Phase 4
21
Earliest trial started Sep 1, 2000 (NCT00482781)
Timeline
2000s
- Jan 1, 2000
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2000
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
- Dec 13, 2002
Earliest FDA Approval
- Dec 13, 2002
GlaxoSmithKline — NDA Secondary Org
- Jun 20, 2008
Sanofi-Aventis — First NDA Organization
- Jun 20, 2008
Sanofi-Aventis — NDA Organization
Indications
Approved for
Studied for
- Bacterial Infections · Phase 3
- BCG Vaccine · Phase 4
- Chickenpox · Phase 3
- Diarrhea · Phase 2
- Diphtheria · Phase 4
- Diphtheria-Tetanus-acellular Pertussis Vaccines · Phase 4
- Diphtheria Toxoid · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drug Therapy, Combination · Phase 4
- Fever · Phase 4
- Haemophilus Infections · Phase 4
- Haemophilus influenzae · Phase 3
- Haemophilus influenzae type b · Phase 4
- Healthy Volunteers · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 3
- Hepatitis B · Phase 4
- Immunity · Phase 4
- Immunization · Phase 3
- Infant · Phase 4
- Malaria Vaccines · Phase 2
- Measles · Phase 3
- Meningitis · Phase 2
- Meningitis, Bacterial · Phase 3
- Meningitis, Meningococcal · Phase 3
- Meningococcal Infections · Phase 3
- Meningococcal Vaccines · Phase 3
- Mumps · Phase 3
- Neisseria meningitidis · Phase 3
- Neoplasms · Phase 2
- Pain · Phase 4
- Pertussis Vaccine · Phase 4
- Pneumococcal Infections · Phase 3
- Pneumococcal Vaccines · Phase 4
- Pneumonia · Phase 3
- Pneumonia, Staphylococcal · Phase 3
- Poliomyelitis · Phase 4
- Poliovirus Vaccines · Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Respiratory Syncytial Virus Vaccines · Phase 3
- Rotavirus Infections · Phase 3
- Rotavirus Vaccines · Phase 3
- Rubella · Phase 3
- Safety · Phase 3
- Salmonella Infections · Phase 2
- Streptococcal Infections · Phase 4
- Tetanus · Phase 4
- Vaccines · Phase 4
- Vaccines, Combined · Phase 4
- Virus Diseases · Phase 3
- Whooping Cough · Phase 4
Mechanism of action
- Diphtheria toxinImmunity, active
Diphtheria toxin immunity, active
- PoliovirusImmunity, active
Poliovirus immunity, active
- Haemophilus influenzaeImmunity, active
Haemophilus influenzae immunity, active
- Hepatitis B virusImmunity, active
Hepatitis B virus immunity, active
- Bordetella pertussisImmunity, active
Bordetella pertussis immunity, active
Approval history
- approvedDec 13, 2002
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaDTaP-IPV-HepB vaccine ↗
- WikipediaPentavalent vaccine ↗
- WikipediaDTaP-IPV/Hib vaccine ↗
Also known as
- diphtheria-tetanus-acellular pertussis-inactivated poliovirus-haemophilus influenzae b conjugate-hepatitis b vaccine
- diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -haemophilus influenzae type b conjugate vaccine
- diphtheria-tetanus- pertussis, hepatitis b and hib combination vaccines
- diphtheria,tetanus,pertussis+polio+hepatitis b+hib
- diphtheria toxoid / filamentous haemagglutinin / hepatitis b surface antigen / pertussis toxoid / tetanus toxoid / haemophilus influenzae type b polysaccharide / polyribosylribitol phosphate conjugated to tetanus protein / type 1 (mahoney) / type 2 (mef-1) / type 3 (saukett)
- diphtheria toxoid/ hepatitis b recombinant surface antigen/ bordetella pertussis (inactivated) /tetanus toxoid
- diphtheria toxoid / tetanus toxoid / bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3 / hepatitis b surface antigen produced in yeast cells / poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.
- diphtheria toxoid / tetanus toxoid / bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis-b surface antigen / poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain))
- diphtheria toxoid / tetanus toxoid / bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis b surface antigen / poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)) / haemophilus influenzae type-b polysaccharide
- diphtheria toxoid / tetanus toxoid / inactivated bordetella pertussis / hepatitis b surface antigen (rdna) / haemophilus influenzae type b polysaccharide
- diphtheria toxoid / tetanus toxoid / pertussis toxoid / pertussis haemagglutin filamentous / pertactin / hepatitisb recombinant surface antigen
- diphtheria toxoid /tetanus toxoid / two-component acellular pertussis(pertussis toxoidand filamentous haemagglutinin ) /inactivated poliomyelitis virus types 1,2 and 3 /haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein / hepatitis-b surface antigen
- dpt-hepb-hib
- dpt-ipv-hib
- dt3ap-hbs-ipv
- dtap(5)-ipv-hib vaccine
- dtap-ipv-hib conjugate vaccine
- dtap-ipv-hib-hbv conjugate vaccine
- dtap-ipv-hib-hbv vaccine
- dtap-ipv-hib-hbv vaccine
- dtpa-hbv-ipv/hib
- dtpa-ipv/hib vaccine
- hybrid 5 component dtap, vero ipv, hep b and prp-ompc
- infanrix hexa
- infanrix hexa
- infanrix hexa vaccine
- pediacel
- pediacel
- pediarix
- pentabio
- pentacel
- pentacel
- pentacel dtap-ipv-hib vaccine
- pentavac
- pentavalent dtwp-rhepb-hib vaccine
- pentaxim
- pentaxim
- pr51
- purified diphtheria toxoid / purified tetanus toxoid / purified pertussis toxoid / purified pertussis filamentous haemagglutinin / hepatitis b surface antigen / inactivated type 1 poliovirus (mahoney) / inactivated type 2 poliovirus (mef 1) / inactivated type 3 poliovirus (saukett) / haemophilus influenzae type b polysaccharide
- shan5
- v441
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07203755 | Phase 1 | Oct 22, 2025 | Government of China, Tianjin Cansino Biotechnology Inc |
| NCT07160244 | Phase 3 | Aug 25, 2025 | Pfizer |
| NCT07112144 | Phase 3 | Jun 13, 2025 | Changchun BCHT Biotechnology Co., Government of China |
| NCT06947499 | Phase 2/Phase 3 (Phase 3) | May 30, 2025 | LG |
| NCT06879327 | Phase 2 | May 30, 2025 | PATH, Pharmassist Ltd |
| NCT06975878 | Phase 3 | May 22, 2025 | Sanofi |
| NCT06690515 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2025 | Padjadjaran University, PT Bio Farma |
| NCT06824181 | Phase 3 | Feb 27, 2025 | Sanofi |
| NCT06824194 | Phase 3 | Feb 18, 2025 | Sanofi |
| NCT06748612 | Phase 4 | Jan 28, 2025 | International Center for Diarrheal Disease Research |
| NCT06736041 | Phase 3 | Dec 16, 2024 | Sanofi-Aventis |
| NCT06663436 | Phase 2 | Nov 4, 2024 | GlaxoSmithKline |
| NCT06647407 | Phase 1/Phase 2 (Phase 2) | Oct 28, 2024 | Sanofi-Aventis |
| NCT06618196 | Phase 2 | Oct 2, 2024 | LG |
| NCT06397768 | Phase 3 | May 13, 2024 | Sanofi-Aventis |
| NCT06413121 | Phase 3 | May 6, 2024 | Serum Institute of India Pvt. Ltd. |
| NCT06213506 | Phase 2 | Jan 15, 2024 | GlaxoSmithKline, Kwame Nkrumah University of Science and Technology |
| NCT06184542 | Phase 1 | Dec 23, 2023 | Chinese Academy of Medical Sciences, Government of China |
| NCT05951725 | Phase 3 | Aug 11, 2023 | Tianjin Cansino Biotechnology Inc |
| NCT05952596 | Phase 1 | Jul 17, 2023 | LG, Seoul National University |
Showing 20 of 134 trials
Page 1 / 7
Organizations
Research & Development (46)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 49 | 48 | 3 | 2000 |
| Sanofi-Aventis | For profit | 22 | 12 | 3 | 2001 |
| Sanofi | For profit | 19 | 19 | 3 | 2001 |
| Merck | For profit | 16 | 11 | 3 | 2001 |
| LG | For profit | 6 | 6 | 3 | 2017 |
| PT Bio Farma | For profit | 5 | 5 | 3 | 2014 |
| Novartis | For profit | 4 | 4 | 2 | 2004 |
| Government of China | Government | 3 | 0 | 2 | 2023 |
| Mitsubishi Tanabe | For profit | 3 | 3 | 1 | 2016 |
| Osaka University | Academic/Hospital | 3 | 0 | 1 | 2016 |
| Pfizer | For profit | 3 | 3 | 2 | 2005 |
| Shantha Biotechnics Limited | For profit | 3 | 3 | 1 | 2008 |
| Dalhousie University | Academic/Hospital | 2 | 2 | 2 | 2010 |
| Government of Indonesia | Government | 2 | 0 | 1 | 2019 |
| Padjadjaran University | Academic/Hospital | 2 | 0 | 2 | 2014 |
| PATH | Academic/Hospital | 2 | 1 | 2 | 2015 |
| Serum Institute of India Pvt. Ltd. | For profit | 2 | 2 | 1 | 2015 |
| Tianjin Cansino Biotechnology Inc | For profit | 2 | 2 | 2 | 2023 |
| Wyeth | For profit | 2 | 0 | 2 | 2003 |
| American SIDS Institute | Academic/Hospital | 1 | 1 | 1 | 2000 |
46 organizations
Page 1 / 3
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Dec 13, 2002 |
| Merck | For profit | NDA2 | Dec 21, 2018 |
| Sanofi-Aventis | For profit | NDA | Jun 20, 2008 |