Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Haemophilus influenza Type b (Hib) Vaccine - TriHIBit [mixture of DTaP vaccine (Tripedia) and Hib vaccine (ActHIB or OmniHIB)]
Status: marketed in U.S.
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; R&D; Tech.; USA mark.
Sanofi Pasteur S.A. – Parent
Aventis Pasteur Inc. – Former
Aventis Pasteur S.A. – Former
Cross ref: See the entries for component vaccines – Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (DTP vaccine; Tripedia) (#431); and Haemophilus influen-zae type b (Hib) vaccines (ActHIB and OmniHIB; #439 and #440). See the entries for Acell-ular Pertussis Vaccine Products (#506); Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#429); Haemophilus b Vaccine Products (#453); Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418).
Description: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Haemophilus influenza type b (Hib) vaccine or TriHIBit is a quadravalent combination vaccine prepared by the person administering the injection by reconstitution (dilution) of lyophilized (freeze-dried) Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate), either ActHIB from Sanofi Pasteur Inc. or comparable Omni-HIB from GlaxoSmithKline Inc., with a DTaP vaccine – Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Tri-pedia) from Sanofi Pasteur Inc. TriHIBit kits from Sanofi Pasteur, contain Tripedia and ActHIB vaccines.
Nomenclature: DTaP-Hib Vaccine/Sanofi [BIO]; TriHIBit [TR]; Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Haemophilus influenzae type b (Hib) vaccine [FDA]; ActHIB Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) reconstituted with Tripedia, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [FDA; from labeling for Tripedia and AcHIB combination package] ; Haemophilus influenzae type b (Hib) vaccine (ActHIB) reconstituted with Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Tripedia) [SY]; DTaP-Hib [SY]; DTPa-HIB [CDC]
Companies.: TriHIBit is manufactured and marketed by Sanofi Pasteur Inc., CBER/FDA est. no. 1277.
FDA class: Biologic
CBER class: Multiple Antigen Preparations
Approvals: Date = 19960927, first approval; PLA
Indications: [extract from "INDICATIONS AND USAGE” section of recent Tripedia product insert/labeling]:
ActHIB or ActHIB combined with AvP DTP vaccine by reconstitution is indicated for the active immunization of infants and children 2 through 18 months of age for the prevention of invasive disease caused by H. influenzae type b and/or diphtheria, tetanus and pertussis. TriHIBit, ActHIB combined with Tripedia by reconstitution, is indicated for the active immunization of children 15 to 18 months of age for prevention of invasive disease caused by H. influenzae type b and diphtheria, tetanus and pertussis. Antibody levels associated with protection may not be achieved earlier than two weeks following the last recommended dose. Only AvP whole-cell DTP, Tripedia or 0.4% Sodium Chloride diluent may be used for reconstitution of lyophilized ActHIB. TriHIBit, ActHIB combined with Tripedia by reconstitution, should not be administered to infants younger than 15 months of age. As with any vaccine, vaccination with ActHIB reconstituted with AvP DTP or ActHIB reconstituted with Tripedia (TriHIBit) or 0.4% Sodium Chloride diluent may not protect 100% of susceptible individuals. A single injection containing diphtheria, tetanus, pertussis and Haemophilus b conjugate antigens may be more acceptable to parents and may increase compliance with vaccination programs. Therefore, in these situations it may be the judgment of the physician that it is of benefit to administer a single injection of whole-cell DTP or DTaP and Haemophilus b conjugate vaccines.
Status: Note, there is no specific product license (PLA or BLA) granted for manufacture of this product. This vaccine has received approval for use in the sense that it is recognized and recommendations are provided for its use by FDA, CDC, and other public health authorities; and its has its own product insert/labeling and approved indications:. The product is marketed by Sanofi Aventis, involving promoting pre-administration mixing of one of two specific Hib vaccines (ActHIB or Omni-HIB) with its DTaP vaccine (Tri-pedia) . This reduces the number of injections required for pediatric vaccination vs. the vaccines administered independently.
In late 2000 and March 2004, CBER/FDA reported that OmniHIB, ActHIB, and TriHIBit were on its “Current list of vaccines using bovine-derived materials from countries on the USDA’s BSE list.” See Vaccine Products entry (#400) for further information about bovine-derived materials in vaccines and bovine spongiform encephalopathy (BSE).
TriHIBit has not received European Union approval.
Medical: The primary immunization series consists of three doses administered at intervals of 4 to 8 weeks. It is recommended that Tripedia (DTaP) be given for all three doses since no interchangeability data on DTaP vaccines exist for the primary series. Combination vaccines containing Hib conjugate vaccine and DTaP are licensed only for use in children aged 15-18 months. Because studies in infants have demonstrated that using a DTaP/Hib combination product may induce a lower immune response to the Hib component, the benefits and risks of using convenient DTaP/Hib combination products, involving few injections and physician/clinic visits (and lower costs) vs. individual DTaP and Hib vaccinations should be considered for primary vaccination in younger infants.
Market: The 2007 Average Wholesale Price (AWP) is $261.80/five dose kit, with a Direct Price (Manufacturer’s discount) of $213.94. These prices include the $3.00/dose ($.75/covered component vaccine) Federal Excise Tax charged by the manufacturer for the federal vaccine injury compensation program.
As reported by the National Immunization Program (NIP), Centers for Disease Control and Prevention (CDC; 7/2007), the Private Sector Cost/Dose (average cost) per dose is $42.89 per package of 5 vials. The CDC Cost/Dose, the cost negotiated by NIP, CDC, for bulk contract purchase for public-sector state and local immunization programs, is $25.91 per package of 5 vials ($24.94 in 2006; $24.62 in 2005). These prices include the $3.00/dose ($.75/covered component vaccine) Federal Excise Tax charged by the manufacturer. Sanofi Pasteur’s contract with NIP, CDC, expires on March 31, 2008.
The Sanofi Pasteur list price (Jan. 2006) is $193.62/package (for 1-14), each package containing five single-dose vials of ActHIB and Tripedia ($38.72/dose); and $162.28/package (for 15-44 packages; $32.46/dose). These prices do not include $.75/component vaccine ($3.00 total) federal excise tax (for funding federal vaccine liability insurance) charged by the manufacturer.
Companies involvement:
Full monograph
443 DTaP-Hib Vaccine/Sanofi
Nomenclature:
DTaP-Hib Vaccine/Sanofi [BIO]
TriHiBit [TR]
Acellular pertussis vaccine plus Haemophilus influenzae type b (Hib) vaccine [FDA]
ActHIB Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) reconstituted with Tripedia, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [FDA; labeling for Tripedia and AcHIB combination package from Aventis Pasteur]
DTaP-Hib [SY]
Haemophilus influenzae type b (Hib) vaccine (ActHIB) reconstituted with Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Tripedia) [SY]
DTPa-HIb [CDC abbrev.]
FDA Class: Biologic PLA
Year of approval (FDA) = 1996
Date of 1st FDA approval = 19960927
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
Mueller and Miller medium
peptone (medium)
aluminum potassium sulfate (alum)
ammonium sulfate
Bacillus anthracis prophylaxis
Diphtheria Toxoid
ethyl ether
formaldehyde
Haemophilus influenzae type b capsular polysaccharide (PRP)
hemagglutinin (HA) antigen, influenza A virus
Pertussis Vaccine Adsorbed, Acellular
polymyxin
polysaccharides
Tetanus Toxoid
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
bovine source warning, BSE country
North American coral snake
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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