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Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)

Generic Name: Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)

Brand Names: Adacel, Boostrix, Daptacel, Diphtheria and Tetanus Toxoids Adsorbed, Infanrix, Kinrix, Pediarix, Pentacel, Quadracel, Td Adsorbed, Tdvax, Tenivac, Vaxelis, Infanrix Hexa

Drug Type: Biotech

CAS Number: 308079-75-6

Unique Ingredient Identifier: IRH51QN26H

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

Diphtheria
Tetanus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults	2025/05/30	NCT06997627	Phase 1	Recruiting	GC Biopharma Corp
Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age	2025/02/13	NCT06824181	Phase 3	Recruiting	Sanofi
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age	2025/02/13	NCT06824194	Phase 3	Recruiting	Sanofi
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age	2024/12/16	NCT06736041	Phase 3	Recruiting	Sanofi Pasteur, a Sanofi Company
PFAS Exposure and Immune Response to Vaccination in Adults	2024/09/19	NCT06588530	Phase 4	Completed	Rutgers, The State University of New Jersey
Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women	2022/03/03	NCT05264662	Phase 4	Active, not recruiting	Farzanah Laher
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)	2021/07/27	NCT04978818	Phase 4	Completed	Johns Hopkins Bloomberg School of Public Health
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants	2018/08/08	NCT03621670	Phase 3	Completed	GlaxoSmithKline
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants	2015/09/07	NCT02543918	Phase 1	Completed	Eli Lilly and Company
A Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants	2014/05/23	NCT02145624	Phase 4	Completed	Public Health England

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KINRIX	GlaxoSmithKline Biologicals SA	58160-812	INTRAMUSCULAR	25 [iU] in 0.5 mL	11/26/2024
BOOSTRIX	A-S Medication Solutions	50090-1377	INTRAMUSCULAR	2.5 [iU] in 0.5 mL	3/31/2025
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN	A-S Medication Solutions	50090-1079	INTRAMUSCULAR	2 [Lf] in 0.5 mL	10/22/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Hexacima	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,France	Authorised	4/17/2013
Infanrix Hexa	GlaxoSmithKline Biologicals S.A.,Rue de l'Institut, 89,B-1330 Rixensart,Belgium	Authorised	10/23/2000
Vaxelis	MCM Vaccine B.V.,Robert Boyleweg 4,2333 CG Leiden,Netherlands	Authorised	2/15/2016
Hexyon	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,France	Authorised	4/17/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	2Lf	5/8/2018
BOOSTAGEN SUSPENSION FOR INJECTION	BioNet-Asia Co., Ltd	SIN16493P	INJECTION, SUSPENSION	2.0 Lf/0.5 ml	5/18/2022
PENTAXIM VACCINE	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN14795P	INJECTION, POWDER, FOR SUSPENSION	min. 30 IU/0.5 mL	6/5/2015
BOOSTRIX VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN11845P	INJECTION	2 iu/0.5 ml	3/9/2002
INFANRIX IPV+HIB VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN10988P	INJECTION	min 30IU/0.5ml	6/25/1999
Tetraxim Vaccine	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN15026P	INJECTION, SUSPENSION	Minimum 30 IU/0.5ml	6/6/2016
Adacel®, Suspension for Injection	Sanofi Pasteur Ltd.	SIN14232P	INJECTION, SUSPENSION	2 Lf	9/20/2012
Synflorix Suspension for Injection (Prefilled Syringe)	GlaxoSmithKline Biologicals SA (Filling), GlaxoSmithKline Biologicals SAS	SIN13775P	INJECTION, SUSPENSION	3-6 μg DT/dose (total DT content)	3/19/2010
HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur Val de Reuil	SIN14834P	INJECTION, SUSPENSION	30 Lf (>= 20 IU)/0.5 mL	8/25/2015
INFANRIX HEXA VACCINE	GLAXOSMITHKLINE BIOLOGICALS SA, GlaxoSmithKline Biologicals, GSK Biologicals SA	SIN12288P	INJECTION	min 30 iu/0.5 ml	5/7/2003

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ADACEL POLIO VACCINE	N/A	Sanofi Hong Kong Limited	N/A	N/A	5/15/2008
BOOSTRIX VACCINE	N/A	葛兰素史克	N/A	N/A	8/8/2001
BOOSTRIX POLIO VACCINE	N/A	葛兰素史克	N/A	N/A	5/31/2007

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe	215536	Sanofi-Aventis Australia Pty Ltd	Medicine	A	9/11/2014
TRIPACEL pertussis vaccine - acellular combined with diphtheria and tetanus toxoids (adsorbed)	63120	Sanofi-Aventis Australia Pty Ltd	Medicine	A	4/23/1998
INFANRIX-IPV 0.5mL injection syringe	159563	GlaxoSmithKline Australia Pty Ltd	Medicine	A	4/30/2009
ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection pre-filled needle-free syringe	297685	Sanofi-Aventis Australia Pty Ltd	Medicine	A	3/29/2018
INFANRIX HEXA injection composite pack (pre-filled syringe and vial)	132881	GlaxoSmithKline Australia Pty Ltd	Medicine	A	1/9/2007
ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection syringe	130919	Seqirus Pty Ltd	Medicine	A	12/11/2006
QUADRACEL 0.5mL injection prefilled syringe	385069	Sanofi-Aventis Australia Pty Ltd	Medicine	A	5/24/2022
ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection vial	130906	Seqirus Pty Ltd	Medicine	A	12/11/2006
BOOSTRIX-IPV 0.5 mL injection syringe	96137	GlaxoSmithKline Australia Pty Ltd	Medicine	A	7/8/2004
VAXELIS DTPa5-HepB-IPV-Hib vaccine suspension for injection in 0.5 mL pre-filled syringe	363251	Maxx Pharma Pty Ltd	Medicine	A	3/23/2022

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