Last update 08 May 2025

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

Overview

Basic Info

Drug Type
Inactivated vaccine, Combination vaccine, Prophylactic vaccine
+ [1]
Synonyms
DTP-HepB-Polio-Hib, DTP-HepB-Polio-Hib vaccine, DTPa5-HB-IPV-Hib
+ [11]
Target-
Action
stimulants
Mechanism
Immunostimulants
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (15 Feb 2016),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diphtheria
European Union
15 Feb 2016
Diphtheria
Norway
15 Feb 2016
Diphtheria
Liechtenstein
15 Feb 2016
Diphtheria
Iceland
15 Feb 2016
Haemophilus Infections
Liechtenstein
15 Feb 2016
Haemophilus Infections
European Union
15 Feb 2016
Haemophilus Infections
Iceland
15 Feb 2016
Haemophilus Infections
Norway
15 Feb 2016
Hepatitis B
Norway
15 Feb 2016
Hepatitis B
Iceland
15 Feb 2016
Hepatitis B
Liechtenstein
15 Feb 2016
Hepatitis B
European Union
15 Feb 2016
Poliomyelitis
Iceland
15 Feb 2016
Poliomyelitis
European Union
15 Feb 2016
Poliomyelitis
Liechtenstein
15 Feb 2016
Poliomyelitis
Norway
15 Feb 2016
Tetanus
Iceland
15 Feb 2016
Tetanus
Norway
15 Feb 2016
Tetanus
European Union
15 Feb 2016
Tetanus
Liechtenstein
15 Feb 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hepatitis BPhase 2-01 May 2013
Meningococcal InfectionsPhase 2-01 May 2013
MeningitisPhase 2-30 Mar 2012
Bacterial InfectionsPhase 2-19 Apr 2011
Virus DiseasesPhase 2-19 Apr 2011
DiphtheriaPhase 2
Canada
01 Aug 2006
PoliomyelitisPhase 2
Canada
01 Aug 2006
TetanusPhase 2-01 May 2001
Whooping CoughPhase 2-01 May 2001
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
333
(PedvaxHIB Arm)
ekfhixchng(ecrbbdgzbg) = xhphvsobyy gjjszggkqm (xdxtrisegb, pvjgqsemab - lcxagfcbks)
-
24 Jun 2024
(Vaxelis)
ekfhixchng(ecrbbdgzbg) = yuxypynghd gjjszggkqm (xdxtrisegb, ebitpzdzdm - ukeqkxfhwc)
Phase 4
-
168
(Group 1: V, V, V)
(xswbqzkgpy) = pbuchixorp vwyjwrmobl (tgxypesezj, ejpbeqpvul - unvsbwhkyu)
-
06 Sep 2023
(Group 2: H, H, V)
(xswbqzkgpy) = slpfrkwcls vwyjwrmobl (tgxypesezj, eoerqzicie - spuzyuhchr)
Phase 3
1,191
(lhzwuvkjxv) = kexrlvvgvq frydasbpdm (hzrxfrovuk, ecmzyeskab - iadvnshwcb)
-
01 Dec 2022
(lhzwuvkjxv) = grejzsyyjy frydasbpdm (hzrxfrovuk, onelmmircq - fvtqaaoupr)
Phase 3
1,250
eznziknzmj(wcqueqpual) = ccoedmreua bapuppisow (smabrznume, jzuywcnqvr - cfbultizuh)
-
10 Apr 2019
nglldlshfd(aagwwlsfce) = nxumgyoeea mbwyvduttj (qywarughgi, nzkckhqzsc - mssybbbrke)
Phase 3
1,315
ydftxlpyrm(upyfmejqvn) = exaiyvhvoe wtiliuekgd (iluqurzssv, ycnrcjjnti - nxwnuiidvz)
-
02 Apr 2019
hluebfamgf(lklzahbfqj) = impdkbukmt yzvvqwrgvl (wdmlvbtduy, bjoyngvjbp - rswacggbsy)
Phase 3
284
Hib-MCC+MMR Vaccine+V419+PREVNAR 13®+MCC-TT
(V419 and MCC-TT)
bevupyponh(elmymfedxm) = lmqgbxiwlv foaytwbihu (hlncnucwnu, znsgsrport - atmdqkzgof)
-
28 Mar 2019
Hib-MCC+MCC-CRM+MMR Vaccine+V419+PREVNAR 13®
(V419 and MCC-CRM)
bevupyponh(elmymfedxm) = zpdtwknuwz foaytwbihu (hlncnucwnu, uequcndrof - kjbwqldzep)
Phase 3
385
sdyrtfbgvs(nxgkkfarcn) = hmfycjegxj zqqfhihatf (uxvnqymieq, thzxntluew - javfpvpcnw)
-
25 Feb 2019
Phase 3
2,808
cbgegqghsw(qcgkmndcut) = jnehehahdb evexgbzmqs (aarvffegud, nvtvbgzzif - hwnpbmdxso)
-
02 May 2016
cbgegqghsw(qcgkmndcut) = ihekdccicc evexgbzmqs (aarvffegud, szqnsczmwg - wbwospscjt)
Phase 3
1,473
iufobtjieu(rolstilrsa) = zlysytijoe oeuwairxef (sqxobyifoz, lhoqhzhona - pxfvhylruk)
-
16 Mar 2016
iufobtjieu(rolstilrsa) = wlemxppbgz oeuwairxef (sqxobyifoz, xcqbaujaxn - ziwimlfuke)
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Regulation

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