Haemophilus b Polysaccharide Vaccine - HIB-Vax
Status: withdrawn from the market
Organizations involved:
Sanofi Pasteur Inc. – Former
Sanofi Pasteur S.A. – Parent.; Former
Cross ref: See the Haemophilus b Vaccine Products entry (#453).
Description: Haemophilus b Polysaccharide Vaccine (HIB-Vax) is an unconjugated Haemophilus influenzae type B poly-saccharide vaccine for which U.S. manufacturing and marketing have been discontinued. This vaccine was replaced by Haemo-philus b conjugate vaccines from Aventis Pasteur, ActHIB (and equivalent OmniHIB marketed by GlaxoSmithKline Inc.) and ProHIBiT (no longer approved).
Nomenclature: Haemophilus b Vaccine/Aventis [BIO]; HIB-Vax [TR]; Haemophilus b Polysaccharide Vaccine [FDA]; HIBVax [SY]; Hib vaccine [SY]; HIB [CDC]
Companies.: The vaccine was manufactured by Connaught Labs., FDA CBER est. no. 0711, now Sanofi Pasteur Inc.. It was marketed in the U.S. by now Connaught Labs., now Sanofi Pasteur Inc.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19851220; first approval, PLA
Date = 19991209; approval revoked from Connaught Labs., Inc. and granted (reissued) to new owner, Aventis Pasteur Inc.
Indications: product insert/labeling not available
Status: The product license was voluntarily withdrawn. It was replaced in the Aventis Pasteur Inc., now Sanofi Pasteur Inc., product line by a Hib conjugate vaccine, ActHIB (see related entry).
Companies involvement:
Full monograph
456 Haemophilus b Vaccine/Aventis
Nomenclature:
Haemophilus b Vaccine/Aventis [BIO]
HIB-Vax [TR]
Haemophilus b Polysaccharide Vaccine [FDA]
Hib vaccine [SY]
HIBVax [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1985
Date of 1st FDA approval = 19851220
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, subunit
bacterial culture <!-- bacterialculture -->
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
EU000 Not yet/Never filed with EU
SM200 Not Available/Not Marketed
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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