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DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR COMPONENT) VACCINE, ADSORBED

Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine; DTaP Vaccine; Acellular DTP

Category Active immunizing agent.

      Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine is a sterile suspension of purified and adsorbed diphtheria and tetanus toxoids and individually purified antigenic components of Bordetella pertussis, which are adsorbed onto suitable adjuvant(s), such as aluminium hydroxide or aluminium phosphate.

      The diphtheria toxoid and tetanus toxoid are prepared from toxins produced by the growth in suitable media of Corynebacterium diphtheriae and Clostridium tetani, respectively, by treatment with formaldehyde.

      The vaccine contains either pertussis toxoid or a pertussis-toxin-like protein free from toxic properties, produced by expression of a genetically modified form of the corresponding gene. Pertussis toxoid is prepared from pertussis toxin by a method that renders the latter harmless while maintaining adequate immunogenic properties and avoiding reversion to toxin. The vaccine may also contain filamentous haemagglutinin, pertactin (a 69 kDa outer-membrane protein) and other defined components of B. pertussis, such as fimbrial-2 and fimbrial-3 antigens. The latter 2 antigens may be copurified. The antigenic composition and characteristics are based on evidence of protection and freedom from unexpected reactions in the target group for which the vaccine is intended.

      The vaccine complies with the requirements stated under Vaccine, with the following modifications.

Description Turbid liquid, white deposit and colourless or white opalescent liquid.

Strength available 30 IU of adsorbed diphtheria toxoid, 40 IU of adsorbed tetanus toxoid, 5 to 25 μg of pertussis toxin (PT), 2.5 to 25 μg of filamentous hemagglutinin (FHA), and may also contain 2.5 to 8 μg of pertactin, with or without 5 μg of fimbrial-2 and fimbrial-3 antigens per 0.5 ml.

Dose Intramuscular, at the anterolateral aspect of the thigh (for children under 1 year of age) or the deltoid muscle of the upper arm (for older children) is preferred, 0.5 ml.

Warning See under DiphtheriaTetanus and Pertussis VaccineAdsorbed, p. 275.

Additional information Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine has been developed to reduce the frequency and severity of both local and systemic adverse reactions associated with Adsorbed Diphtheria, Tetanus and Pertussis Vaccine. 

       See also under DiphtheriaTetanus and Pertussis VaccineAdsorbed, p. 275.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 3 years from the date of the last satisfactory test for potency.

Labelling Complies with the labelling described under the “General Information for Biological Products”, p.177. In addition the label on the container states (1) the minimum number of IU of diphtheria and tetanus toxoid per single human dose; (2) the names and amounts of the pertussis components per single human dose; (3) the name and the amount of the adjuvant(s); (4) that it is not to be frozen; (5) that it must be well shaken before use; (6) where applicable, that the vaccine is intended for primary vaccination of children and is not necessarily suitable for reinforcing doses or for administration to adults; (7) where applicable, that the vaccine contains a pertussis toxin-like protein produced by genetic modification. 

Identification Complies with the tests for Identification of Diphtheria VaccineAdsorbed, p. 245, of Tetanus Vaccine, Adsorbed, p. 273, and of Pertussis Vaccine (Acellular Component), Adsorbed, p. 263.

pH 5.8 to 7.2 (Appendix 4.11).

Absence of residual pertussis toxin and irreversibility of pertussis toxoid

      (Note This test is not necessary for the product obtained by genetic modification.) Use three groups each of not less than five histamine-sensitive mice. Inject intraperitoneally into the first group twice the single human dose of the vaccine stored at 2º to 8º. Inject intraperitoneally into the second group twice the single human dose of the vaccine incubated at 37º for 4 weeks. Inject diluent into the third group of mice. After 5 days, inject into each mouse 2 mg of histamine base intraperitoneally in a volume not exceeding 0.5 ml and observe for 24 hours. The test is invalid if one or more control mice die following histamine challenge.

The vaccine complies with the test if no animal in the first or second group dies following histamine challenge. If one mouse dies in either or both of the first and second groups, the test may be repeated with the same number of mice or with a greater number and the results of valid tests combined; the vaccine complies with the test if, in both of the groups given the vaccine, not more than 5 per cent of the total number of mice die following histamine challenge.

      The histamine sensitivity of the strain of mice used is verified at suitable intervals as follows: inject intravenously threefold dilutions of a reference pertussis toxin preparation in phosphate-buffered saline solution containing 0.2 per cent w/v of gelatin and challenge with histamine as above; the strain is suitable if more than 50 per cent of the animals are sensitized by 50 ng of pertussis toxin and none of the control animals injected with only diluent and challenged similarly with histamine show symptoms of sensitization.

Antimicrobial preservative Where applicable, determine the amount of antimicrobial preservative by a suitable chemical or physico-chemical method. The content is not less than the minimum amount shown to be effective and is not more than 115 per cent of the quantity stated on the label.

Specific toxicity Complies with the test for Specific toxicity described under Diphtheria VaccineAdsorbed, p. 245, and Tetanus VaccineAdsorbed, p. 273.

Assay

      Diphtheria component Carry out the “Biological Assay of Adsorbed Diphtheria Vaccine” (Appendix 15.3.1). The lower confidence limit (P = 0.95) of the estimated potency is not less than the minimum potency stated on the label. Unless otherwise justified and authorized, the minimum potency stated on the label is 30 IU per single human dose (0.5 ml).

      Tetanus component Carry out the “Biological Assay of Adsorbed Tetanus Vaccine” (Appendix 15.3.3). The lower confidence limit (P = 0.95) of the estimated potency is not less than 40 IU per single human dose (0.5 ml).

      Pertussis component Complies with the Assay under Pertussis Vaccine (Acellular Component), Adsorbed, p. 264.

MONOGRAPHS • DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR COMPONENT) VACCINE, ADSORBED
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หมายเหตุ / Note : TP II 2011 PAGE 276-277