Clostridium tetani toxoid antigen (formaldehyde inactivated)

Overview

Clostridium tetani toxoid antigen (formaldehyde inactivated) is a vaccine for intramuscular injection. It is used for active immunization of children 7 years of age or older, and adults, for prevention of tetanus. The toxoid in the Clostridium tetani culture is grown and detoxified followed by purification via ammonium sulfate filtration and precipation.

Indication

No indication information available.

Associated Conditions

Diphtheria
Pertussis
Tetanus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants	2025/04/23	NCT06939777	Phase 1	Not yet recruiting	Sinovac Life Sciences Co., Ltd.
Routine Antibiotic vs. Directed Antibiotic Treatment in Snake Bite	2015/10/07	NCT02570347	Phase 4	Terminated	Jawaharlal Institute of Postgraduate Medical Education & Research

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PEDIARIX	A-S Medication Solutions	50090-7541	INTRAMUSCULAR	10 [iU] in 0.5 mL	8/13/2025
KINRIX	GlaxoSmithKline Biologicals SA	58160-812	INTRAMUSCULAR	10 [iU] in 0.5 mL	11/26/2024
BOOSTRIX	A-S Medication Solutions	50090-1377	INTRAMUSCULAR	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	5 [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

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TETAVAX single dose, suspension for injection in a prefilled syringe	SANOFI PASTEUR	SIN13657P	SUSPENSION, STERILE	40 I.U. / 0.5ml dose	6/16/2009
IMOVAX d.T., SUSPENSION FOR INJECTION IN 0.5 mL PRE-FILLED SYRINGE	Sanofi Pasteur (VDR)	SIN16995P	INJECTION, SUSPENSION	≥ 20 IU/ 0.5mL	4/30/2024
BOOSTAGEN SUSPENSION FOR INJECTION	BioNet-Asia Co., Ltd	SIN16493P	INJECTION, SUSPENSION	7.5 Lf/0.5 ml	5/18/2022
Adacel®, Suspension for Injection	Sanofi Pasteur Ltd.	SIN14232P	INJECTION, SUSPENSION	5 Lf	9/20/2012
PENTAXIM VACCINE	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN14795P	INJECTION, POWDER, FOR SUSPENSION	min. 40 IU/0.5 mL	6/5/2015
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	5Lf	5/8/2018
BOOSTRIX VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN11845P	INJECTION	20 iu/0.5 ml	3/9/2002
INFANRIX IPV+HIB VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN10988P	INJECTION	min 40IU/0.5ml	6/25/1999
BOOSTRIX POLIO SUSPENSION FOR INJECTION	GlaxoSmithKline Biologicals SAS	SIN15888P	INJECTION, SUSPENSION	5.0 Lf/0.5ml - not less than 20 IU	2/20/2020
Tetraxim Vaccine	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN15026P	INJECTION, SUSPENSION	Minimum 40 IU/0.5ml	6/6/2016

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
HIBERIX haemophilus influenzae type B conjugate 10microgram/0.5mL injection vial and diluent syringe	60881	GlaxoSmithKline Australia Pty Ltd	Medicine	A	10/28/1997
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

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BOOSTRIX	GlaxoSmithKline Inc	02247600	Suspension - Intramuscular	20 UNIT / 0.5 ML	5/29/2007
DPT POLIO ADSORBED VACCINES	aventis pasteur limited	00605050	Liquid - Intramuscular	5 LF / 0.5 ML	12/31/1984
INFANRIX-IPV	GlaxoSmithKline Inc	02241284	Suspension - Intramuscular	40 UNIT / 0.5 ML	10/25/2012
TD ADSORBED	Sanofi Pasteur Limited	02528401	Suspension - Intramuscular	5 LF / 0.5 ML	4/9/2024
T POLIO ADSORBED	aventis pasteur limited	00610801	Liquid - Intramuscular	5 UNIT / 0.5 ML	7/26/1984
QUADRACEL	Sanofi Pasteur Limited	02534789	Suspension - Intramuscular	5 LF / 0.5 ML	5/6/2024
PEDIACEL	Sanofi Pasteur Limited	02243167	Suspension - Intramuscular	5 LF / 0.5 ML	10/4/2007
BOOSTRIX-POLIO	GlaxoSmithKline Inc	02312557	Suspension - Intramuscular	5.0 LF / 0.5 ML	10/22/2010
TETANUS TOXOID ADSORBED INJ	aventis pasteur limited	00491500	Liquid - Intramuscular	5 LF / 0.5 ML	12/31/1980
TRI-IMMUNOL LIQ IM	lederle labs, division of american cyanamid co	02019981	Liquid - Intramuscular	5 LF / 0.5 ML	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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