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Diphtheria

27
Pipeline Programs
14
Companies
50
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
4
1
16
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
35100%
+ 50 programs with unclassified modality

Competitive Landscape

13 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
22 programs
2
11
4
Boostrix TMPhase 4
DTPa-HBV-IPV/HibPhase 4
GSK Biologicals' combined DTPa-IPV/Hib vaccinePhase 4Vaccine
Infanrix hexaPhase 4
BoostrixPhase 3
+17 more programs
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
2 programs
1
1
V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis BPhase 3
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCPhase 2
MSD
MSDIreland - Ballydine
2 programs
1
1
V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis BPhase 31 trial
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCPhase 21 trial
Active Trials
NCT00362427Completed460Est. Mar 2009
NCT00092469Completed151Est. Aug 2003
Biomed
BiomedAustralia - Sydney
1 program
1
ClodivacPhase 3
IBSS Biomed
IBSS BiomedPoland - Krakow
1 program
1
ClodivacPhase 31 trial
Active Trials
NCT05480462Unknown200Est. Jun 2024
Sandoz
SandozAustria - Kundl
1 program
1
DTwP-HepB-Hib VaccinePhase 3Vaccine1 trial
Active Trials
NCT01470287Completed175Est. Apr 2012
CanSino Biologics
CanSino BiologicsChina - Tianjin
3 programs
2
1
Tetanus, Reduced Diphtheria and Acellular PertussisPhase 2/31 trial
Diphtheria,Tetanus and Acellular PertussisPhase 11 trial
Tetanus, Reduced Diphtheria and Acellular PertussisPhase 11 trial
Active Trials
NCT04099303Completed400Est. Nov 2021
NCT06056050Active Not Recruiting180Est. Sep 2025
NCT06708286Active Not Recruiting1,820Est. May 2025
Sanofi
SanofiPARIS, France
27 programs
DTaP-IPV/HibN/A1 trial
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCPHASE_2
Adacel®PHASE_35 trials
Concomitant administrationPHASE_32 trials
DAPTACEL®.PHASE_31 trial
+22 more programs
Active Trials
NCT00804284Completed62,538Est. Jan 2015
NCT02992418Terminated688Est. Dec 2019
NCT01689324Completed43Est. May 2013
+41 more trials
GSK
GSKLONDON, United Kingdom
22 programs
Boostrix®N/A1 trial
Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [RefortrixN/AVaccine1 trial
GSK Biologicals' Infanrix™N/A1 trial
InfanrixN/A1 trial
Pertussis maternal immunizationN/A1 trial
+17 more programs
Active Trials
NCT00297856Completed10,000Est. Dec 2006
NCT02757950Completed2,462Est. May 2017
NCT00908115Completed1,258Est. Jun 2008
+19 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Pilot Study Freeze and Transport Immune CellsN/A1 trial
Active Trials
NCT00138268Completed12Est. Feb 2005
Vabiotech
VabiotechVietnam - Hanoi
1 program
Study subjects will be vaccinated with 3N/A1 trial
Active Trials
NCT03931239Completed222Est. Jul 2018
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCPHASE_2
Novartis
NovartisBASEL, Switzerland
1 program
DTwP-HepB-Hib VaccinePHASE_3Vaccine

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKDTPa-HBV-IPV/Hib
GSKInfanrix hexa
SanofiAdacel®
SanofiDiphtheria, tetanus, polio and pertussis vaccination
GSKBoostrix TM
SanofiDTacP-IPV combined vaccine
SanofiAdacel®
SanofiTetanus and Diphtheria Toxoids Adsorbed
SanofiAdacel®
SanofiDiphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
GSKGSK Biologicals' combined DTPa-IPV/Hib vaccine
SanofiTetanus and Diphtheria Toxoids Adsorbed
SanofiDiphtheria and Tetanus Toxoids and Acellular Pertussis
SanofiDiphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
IBSS BiomedClodivac

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 37,755 patients across 50 trials

NCT04535037GSKDTPa-HBV-IPV/Hib

A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers

Start: May 2021Est. completion: Jul 2022500 patients
Phase 4Completed
NCT02853929GSKInfanrix hexa

Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

Start: Sep 2016Est. completion: Mar 2019551 patients
Phase 4Completed

Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Start: Jun 2012Est. completion: Jun 2013423 patients
Phase 4Completed
NCT01546909SanofiDiphtheria, tetanus, polio and pertussis vaccination

Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

Start: Feb 2012Est. completion: Dec 2012278 patients
Phase 4Completed
NCT01362322GSKBoostrix TM

Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

Start: Jul 2011Est. completion: Sep 2012671 patients
Phase 4Completed
NCT01031303SanofiDTacP-IPV combined vaccine

Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Start: Dec 2009Est. completion: Jan 2011123 patients
Phase 4Completed

Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

Start: Jun 2008Est. completion: Dec 2009769 patients
Phase 4Completed
NCT00457249SanofiTetanus and Diphtheria Toxoids Adsorbed

A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

Start: Mar 2007Est. completion: Nov 20081,564 patients
Phase 4Completed

Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Start: May 2006Est. completion: Dec 2008647 patients
Phase 4Completed
NCT00255021SanofiDiphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac

Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

Start: Dec 2005Est. completion: Jan 2009186 patients
Phase 4Completed
NCT00325156GSKGSK Biologicals' combined DTPa-IPV/Hib vaccine

Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

Start: Nov 2004Est. completion: Aug 20072,590 patients
Phase 4Completed
NCT00601835SanofiTetanus and Diphtheria Toxoids Adsorbed

Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td

Start: May 2004Est. completion: Jul 20053,651 patients
Phase 4Completed
NCT00802867SanofiDiphtheria and Tetanus Toxoids and Acellular Pertussis

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Start: Feb 2004Est. completion: Sep 2005989 patients
Phase 4Completed
NCT00254917SanofiDiphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

Start: Oct 2003Est. completion: Feb 2006387 patients
Phase 4Completed

Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

Start: Dec 2022Est. completion: Jun 2024200 patients
Phase 3Unknown
NCT03128489GSKInfanrix-IPV/Hib

Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants

Start: Dec 2017Est. completion: Aug 20180
Phase 3Withdrawn

Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

Start: Dec 2016Est. completion: Dec 2019688 patients
Phase 3Terminated
NCT02858440GSKInfanrix-IPV/Hib

A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia

Start: Sep 2016Est. completion: Nov 2018235 patients
Phase 3Completed
NCT02094833SanofiDTaP-IPV-Hep B-PRP~T combined vaccine

DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

Start: Mar 2014Est. completion: Nov 2016310 patients
Phase 3Completed
NCT01988857GSKBoostrix™

Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

Start: Feb 2014Est. completion: May 2014302 patients
Phase 3Completed
NCT01948193SanofiHexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

Start: Feb 2014Est. completion: Jun 2015177 patients
Phase 3Completed
NCT01983540SanofiDTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine

Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

Start: Oct 2013Est. completion: Dec 2015558 patients
Phase 3Completed
NCT01839175SanofiConcomitant administration

Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination

Start: Apr 2013Est. completion: Feb 2015350 patients
Phase 3Completed

Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

Start: Jul 2012Est. completion: Jun 2013300 patients
Phase 3Completed
NCT01470287SandozDTwP-HepB-Hib Vaccine

Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

Start: Dec 2011Est. completion: Apr 2012175 patients
Phase 3Completed
NCT01444781SanofiDTaP-IPV-Hep B-PRP~T combined vaccine

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

Start: Sep 2011Est. completion: Oct 20131,106 patients
Phase 3Completed
NCT01346293SanofiDiphtheria and Tetanus Toxoids and Acellular Pertussis

Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

Start: Apr 2011Est. completion: Sep 20133,372 patients
Phase 3Completed
NCT01287949SanofiDiphtheria, tetanus, polio and pertussis vaccination

Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older

Start: Jan 2011Est. completion: May 2012342 patients
Phase 3Completed
NCT01249183SanofiConcomitant administration

Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

Start: Oct 2010Est. completion: Sep 2011954 patients
Phase 3Completed
NCT01214889SanofiPENTAXIM™: DTacP IPV//PRP~T combined vaccine

Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Start: Sep 2010Est. completion: Dec 2011370 patients
Phase 3Completed
NCT01177722SanofiDTaP-IPV-Hep B-PRP-T Vaccine

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Start: Aug 2010Est. completion: Dec 20111,375 patients
Phase 3Completed
NCT01062477SanofiDTaP//PRP-T Combined Vaccine

A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

Start: Jan 2010Est. completion: Dec 20111,056 patients
Phase 3Completed

A Study to Assess the Safety of Adacel® Vaccine

Start: Dec 2009Est. completion: Apr 201030 patients
Phase 3Completed
NCT00797511SanofiTdcP-IPV vaccine

Immunogenicity and Safety of Adacel Polio Vaccine

Start: Nov 2008Est. completion: Jul 2009132 patients
Phase 3Completed
NCT00831753SanofiDTaP IPV HB PRP~T vaccine

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

Start: May 2008Est. completion: Nov 2009263 patients
Phase 3Completed
NCT00654901SanofiDTaP-IPV-Hep B-PRP~T vaccine

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

Start: Mar 2008Est. completion: Jul 2009881 patients
Phase 3Completed
NCT00534833SanofiDTaP-HB-PRP~T combined vaccine

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

Start: Sep 2007Est. completion: Mar 2009362 patients
Phase 3Completed

Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

Start: Mar 2007Est. completion: May 2007660 patients
Phase 3Completed
NCT00453570SanofiDiphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

Start: Mar 2007Est. completion: Jan 2009792 patients
Phase 3Completed
NCT00343889SanofiDTaP-HB-PRP~T vaccine + OPV

Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Start: Aug 2006Est. completion: Apr 2008379 patients
Phase 3Completed
NCT00315055SanofiDTaP-IPV-Hep B-PRP~T combined vaccine

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Start: Jul 2006Est. completion: Feb 2008310 patients
Phase 3Completed
NCT00343421SanofiPEDIACEL® and Prevenar®

Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

Start: Jul 2006Est. completion: Jun 2009588 patients
Phase 3Completed
NCT00313911SanofiDTaP-IPV-Hep B-PRP~T combined vaccine

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Start: Jul 2006Est. completion: Feb 20082,133 patients
Phase 3Completed
NCT00348881SanofiDTaP-HB-PRP~T combined vaccine

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Start: Jun 2006Est. completion: Jun 20082,133 patients
Phase 3Completed
NCT00320463GSKDTPa-HBV-IPV/Hib vaccine

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Start: Apr 2006Est. completion: Jan 2007415 patients
Phase 3Completed
NCT00259337SanofiDiphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Immunogenicity and Safety of Pentaxim™ in an Indian Population

Start: Feb 2006Est. completion: Dec 2008226 patients
Phase 3Completed
NCT00316147GSKDTPa-HBV-IPV/Hib vaccine

Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

Start: Dec 2005Est. completion: Aug 2006224 patients
Phase 3Completed

Safety and Immune Response of Different Pediatric Combination Vaccines.

Start: Nov 2005Est. completion: Feb 20092,167 patients
Phase 3Completed
NCT00254969SanofiDiphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Immunogenicity and Safety of Pentaxim in South African Infants

Start: Oct 2005Est. completion: Jan 2010212 patients
Phase 3Completed
NCT00258895SanofiDAPTACEL®: DTaP

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Start: Mar 2005Est. completion: Apr 2007649 patients
Phase 3Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

16 late-stage (Phase 3) programs, potential near-term approvals
14 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.