Adacel®
(tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed)
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Adsorbed
Adacel® , Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration. After shaking, the vaccine is a white, homogenous, cloudy suspension. Neither the vial nor the syringe for this product contain natural latex rubber.
Each dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine (0.5 mL) contains the following active ingredients:
| Acellular Pertussis | |
| Detoxified Pertussis Toxin (PT) | 2.5 μg |
| Filamentous Hemagglutinin (FHA) | 5 μg |
| Pertactin (PRN) | 3 μg |
| Fimbriae Types 2 and 3 (FIM) | 5 μg |
| Tetanus Toxoid (T) | 5 Lf |
| Diphtheria Toxoid (d) | 2 Lf |
Other ingredients per dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤ 5 μg residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL® , Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP); however, Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is formulated with reduced quantities of d and detoxified PT.
The acellular pertussis vaccine components are obtained from Bordetella pertussis cultures grown in Stainer-Scholte medium (1) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate.
Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (2) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.
The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.
Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of the acellular pertussis vaccine components is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).
You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...
Read All Potential Side Effects and See Pictures of Adacel »
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...
REFERENCES
You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...
Read All Potential Side Effects and See Pictures of Adacel »
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...
1 Stainer DW, et al. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...
Read All Potential Side Effects and See Pictures of Adacel »
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...
2 Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...
Read All Potential Side Effects and See Pictures of Adacel »
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...
3 Mueller JH, et al. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...
Read All Potential Side Effects and See Pictures of Adacel »
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...
Last reviewed on RxList: 1/6/2009
This monograph has been modified to include the generic and brand name in many instances.
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