Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) - Kinrix
Status: BLA approved in June 2008
Organizations involved:
GlaxoSmithKline Biologicals S.A. – Manuf.; R&D; Tech.
GlaxoSmithKline Inc. – USA mark.
GlaxoSmithKline plc – Parent
Cross ref.: See the entries for component vaccines – Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (DTP vaccine; Infanrix) (#431); and Poliovirus Vaccine Inactivated (Human Diploid Cell) (Poliovax; #519). See the entries for Acellular Pertussis Vaccine Products (#506); Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#429); Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418).
Description: Kinrix an quadravalent (4-antigen) booster formulation essentially combining the antigens in Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix) with Poliovirus Vaccine Inactivated, i.e., is DTaP plus inactivated polio vaccine (IPV).
Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 µg of inactivated pertussin toxin (PT), 25 µg of filamentous hemagglutinin (FHA), 8 µg of pertactin (69 kDa outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in Infanrix and Pediarix and the poliovirus component is the same as that in Pediarix.
Kinrix is only used as a booster vaccine. It is indicated for the fifth DTaP dose and fourth dose of IPV in 4 to 6 year olds whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix. With the introduction of Kinrix, eligible 4 to 6 year-olds can receive protection against four diseases with one less injection.
Kinrix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes. Each 0.5-mL dose contains a suspension for injection of diphtheria and tetanus toxoids, acellular pertussis antigens, and inactivated poliovirus types 1, 2, and 3.
As indicated by product insert warnings, Kinrix may contain traces of neomycin and polymyxin.
Nomenclature; DTaP-IPV/Sanofi [BIO]; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine [FDA]; Kinrix [TR]; Infanrix plus IPV [SY]; NDC 58160-812-11 and NDC 58160-812-46 [NDC]
Companies.: This vaccine was developed, is manufactured and will be marketed by GlaxoSmithKline (GSK). Presumably, the vaccine, like similar combination vaccines, Kinrix manufactured by GlaxoSmithKline Biologicals S.A., (Rixensart, Belgium), CBER/FDA est. 1617, and marketed in the U.S. by GlaxoSmithKline Inc.
FDA class: Biologics BLA
Approvals: Date = 20080624; BLA
Indications: [full text of the "INDICATIONS AND USAGE” section of product insert/labeling];
A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] for the first three doses and INFANRIX for the fourth dose.
Status: On June 13, 2007, FDA accepted for filing a BLA filed by GSK for this new DTaP-IPV pediatric booster vaccine for immunization against diphtheria, tetanus, whooping cough (pertussis), and polio diseases in children 4 through 6 years of age. In early Feb. 2007, FDA issued a “complete response letter” requesting additional information.
On June 24, 2008, the BLA for Kinrix was approved by FDA. This DTaP-IPV combination vaccine delivers overall protection with one less shot, compared to use of other combination vaccines. This is the first DTaP-IPV vaccine in the U.S. Previously, 4 to 6 year-old DTaP and IPV vaccinations are given as two separately administered shots.
Trials: Clinical studies of Kinrix have shown that this combination vaccine offers similar protection to the separately administered Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV) vaccines, with a comparable safety profile. These results were confirmed in the pivotal Phase III trial, which was a randomized, controlled study conducted in the U.S. in which 3,156 children 4 to 6 years of age vaccinated with Kinrix. All children studied had previously received four doses of DTaP (Infanrix) and three doses of IPV (IPOL). All children in the study also received the second dose of U.S.-licensed measles, mumps and rubella (MMR) vaccine (M-M-R II) at the same time at a separate site. Children receiving the combination vaccine demonstrated an overall comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.
Medical: Kinrix is administered as a 0.5-mL dose by intramuscular injection into the deltoid muscle of the upper arm.
Companies involvement:
Full monograph
446 DTaP-IPV/GSK
Nomenclature:
Diphtheria, Tetanus, Pertussis (Acellular, Component) and Poliomyelitis (Inactivated) Vaccine, adjuvanted []
NDC 58160-812-11 and NDC 58160-812-46 [NDC]
DTaP-IPV/GSK [BIO]
Kinrix [TR]
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine [FDA]
Infanrix plus IPV [SY]
FDA Class: Biologic BLA
Year of approval (FDA) = 2008
Date of 1st FDA approval = 20080324
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
vaccines, viral
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
polio prophylaxis
acellular Pertussis Vaccine
Diphtheria Toxoid
implants
neomycin
pertussis toxin (PT)
Pertussis Vaccine Adsorbed, Acellular
polymerase chain reaction (PCR)
Tetanus Toxoid
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
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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