Poliovirus type 3 antigen (formaldehyde inactivated)

Overview

Poliovirus type 3 antigen is a suspension of poliovirus Type 3 (Saukett) used in the active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Type 3. The vaccine contains purified and inactivated poliovirus type 3 that were grown from a continuous line of monkey kidney cells.

Indication

No indication information available.

Associated Conditions

Poliomyelitis caused by Poliovirus
Poliomyelitis caused by poliovirus type 1

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults	2023/10/26	NCT06101173	Phase 1	Completed	CanSino Biologics Inc.
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects	2012/09/18	NCT01686503	Phase 2	Completed	Eastern Virginia Medical School

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KINRIX	GlaxoSmithKline Biologicals SA	58160-812	INTRAMUSCULAR	32 [iU] in 0.5 mL	11/26/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
IMOVAX POLIO INJECTION	SANOFI PASTEUR	SIN10608P	INJECTION	8 D.U./0.5 mL	1/6/1999
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	8 D-antigen units	5/8/2018
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	32 D-antigen units	5/8/2018
HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur Val de Reuil	SIN14834P	INJECTION, SUSPENSION	32 DU/0.5 mL	8/25/2015
INFANRIX HEXA VACCINE	GLAXOSMITHKLINE BIOLOGICALS SA, GlaxoSmithKline Biologicals, GSK Biologicals SA	SIN12288P	INJECTION	32 du/0.5 ml	5/7/2003
BOOSTRIX POLIO SUSPENSION FOR INJECTION	GlaxoSmithKline Biologicals SAS	SIN15888P	INJECTION, SUSPENSION	32 DU/0.5 ml	2/20/2020
Tetraxim Vaccine	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN15026P	INJECTION, SUSPENSION	32 DU/0.5ml	6/6/2016
PENTAXIM VACCINE	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN14795P	INJECTION, POWDER, FOR SUSPENSION	32 DU/0.5 mL	6/5/2015

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
INFANRIX-IPV	GlaxoSmithKline Inc	02241284	Suspension - Intramuscular	32 UNIT / 0.5 ML	10/25/2012
PEDIACEL	Sanofi Pasteur Limited	02243167	Suspension - Intramuscular	26 UNIT / 0.5 ML	10/4/2007
BOOSTRIX-POLIO	GlaxoSmithKline Inc	02312557	Suspension - Intramuscular	32 D / 0.5 ML	10/22/2010
INFANRIX-IPV/HIB	GlaxoSmithKline Inc	02257122	Suspension - Intramuscular	32 UNIT / 0.5 ML	10/25/2012

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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