Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed - Tri-Immunol
Status: withdrawn from the U.S. market
Organizations involved:
Lederle Labs. – Former
Wyeth – Parent; Former
Cross ref: See the entries for Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#427); Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418). See the entries for component Diphtheria & Tetanus Toxoids Adsorbed (#426) from Lederle Labs./Wyeth.
Description: Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed or Tri-Immunol was a combination vaccine formulated by mixture of three vaccines – Tetanus Toxoid Adsorbed, Diphtheria Toxoid Adsorbed, and Pertussis Vaccine Adsorbed manufactured by the Lederle facilities of Wyeth-Ayerst Labs. Besides use as a DTP vaccine, this vaccine was used as a component in the manufacture of DTP + Haemophilus influenzae type B vaccine (Tetra-mune) by Lederle/Wyeth.
Nomenclature: DTP Vaccine/Lederle [BIO]; Tri-Immunol [TR]; Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed [FDA]; Diphtheria and Tetanus Toxoids and Pertussis Vaccine Combined Aluminum Phosphate Adsorbed [FDA former until July 1970]; Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed USP [USP]; DTP Vaccine [SY]
Companies.: This vaccine was manufactured by Lederle Labs. (Pearl River, NY), FDA CBER est. no. 0017, now Wyeth.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19480324; first approval of DTP adsorbed vaccine from Lederle Labs.
Date = 19700724; first approval date according to the current CBER/FDA database; However, FDA letter on this date states the product license revoked and granted (reissued) using the new FDA proper (generic) name.
Date = 19700729, first approval, according to Wyeth
Date = 19980814; approval withdrawn according to CBER/FDA database
Date =19981001; approval withdrawn according to Wyeth
Indications: product insert/labeling not available
Status: This vaccine is no longer approved, manufactured or marketed. Approval was voluntarily withdrawn.
Companies involvement:
Full monograph
449 DTP Vaccine/Lederle
Nomenclature:
DTP Vaccine/Lederle [BIO]
Tri-Immunol [TR]
Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed [FDA]
Diphtheria and Tetanus Toxoids and Pertussis Vaccine Combined Aluminum Phosphte Adsorbed [FDA former until July 1970]
Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed USP [USP]
DTP Vaccine [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1948
Date of 1st FDA approval = 19480314
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
Mueller and Miller medium
aluminum phosphate
Diphtheria Toxoid
Pertussis Vaccine Adsorbed
Tetanus Toxoid
thimerosal (mercury derivative)
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)
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
EU011 Approved Formerly in EU/withdrawn
SM200 Not Available/Not Marketed
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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