Neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen

Overview

Neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen is an active intramuscular immunization for the prophylaxis of invasive meningococcal disease caused by Neisseria meningitidis serogroup c. The vaccine contains N. meningitis serogroup c capsular polysaccharide antigens that are purified and individually conjugated to diphtheria toxoid protein that are extracted from Corynebacterium diphtheriae grown in another culture.

Indication

No indication information available.

Associated Conditions

Invasive Meningococcal Infection caused by Neisseria meningitidis serogroup C

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali	2019/04/17	NCT03917654	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds	2017/09/27	NCT03295318	Phase 2	Completed	Serum Institute of India Pvt. Ltd.
Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali	2016/10/24	NCT02942277	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali	2015/01/08	NCT02334462	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION	Catalent Belgium S.A. (diluent in pre-filled syringe), Pfizer Manufacturing Belgium NV (diluent in pre-filled syringe), Pfizer Manufacturing Belgium NV, GlaxoSmithKline Biologicals SA	SIN14534P	INJECTION, POWDER, FOR SOLUTION	5 micrograms	4/3/2014

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
No Health Canada approvals found for this drug.

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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