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TYPHOID VACCINE, ORAL

Typhoid (Strain Ty 21a) Vaccine, Live (Oral)

Category Active immunizing agent.

      Oral Typhoid Vaccine is a freeze-dried preparation of live Salmonella typhi strain Ty 21a grown in a suitable medium.

      The vaccine complies with the requirements stated under Vaccines, with the following modification. 

Description Dull whitish powder. 

Strengths available Two to 6 × 109 CFU of viable Salmonella typhi strain Ty 21a per capsule.

Dose Adults and children 6 years of age and older: one capsule.

Contra-indication It is contra-indicated in individuals who are immunosuppressed and in acute gastrointestinal illness. 

Warning 

1. Mild gastro-intestinal disturbances or a transitory exanthema may occur in high-risk areas.

2. Caution should be excercised when it is to be used concomitantly with antibacterials or antimalarials.

Additional information Swallow the vaccine capsule about 1 hour before a meal with a cold or lukewarm drink not exceeding 37º. Do not chew the vaccine capsule; swallow as soon as possible.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 1 year from the date of the last satisfactory tests.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the minimum number of live bacteria per dosage unit; (2) that the vaccine is for oral use only.

Identification Culture bacteria from the vaccine to be examined on an agar medium containing 1 per cent of galactose and bromothymol blue. Light blue, concave colonies, transparent due to lysis of cells, are formed. No yellow colonies (galactose-fermenting) are found.

Microbial purity Carry out the test described under “Microbial Limit Tests” (Appendix 10.2), using suitable selective media. Determine the total aerobic microbial count (TAMC) and total combined yeasts and moulds count (TYMC), using the plate-count method. The number of contaminating micro-organisms per dosage unit is not more than 2 × 102 CFU of TAMC and 20 CFU of TYMC. No pathogenic bacterium, particularly Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and no salmonella other than strain Ty 21a are found.

Water 1.5 to 4.0 per cent w/w (Karl Fischer Method, Appendix 4.12), determined on the contents of the capsule.

Number of live bacteria Carry out the test using not fewer than five dosage units of vaccine. Homogenize the contents of the dosage units in saline TS at 4º using a mixer in a cold room with sufficient glass beads to emerge from the liquid. Immediately after homogenization prepare a suitable dilution of the suspension using cooled diluent and inoculate on brain heart infusion agar; incubate at 36º±1º for 20 to 36 hours. The vaccine contains not less than 2 × 109 live S. typhi Ty 21a bacteria per dosage unit.

Other requirements Complies with the requirements described under “Capsules” (Appendix 1.16).

MONOGRAPHS • TYPHOID VACCINE, ORAL
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หมายเหตุ / Note : TP II 2011 PAGE 280