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Category Active immunizing agent.

      Live Measles Vaccine is a freeze-dried preparation of a suitable attenuated strain of measles virus, propagated in human diploid cells or in cell cultures of chick-embryo derived from a chicken flock free from specified pathogens. The vaccine does not contain any added preservative.

      The vaccine, reconstituted as stated on the label, complies with the requirements stated under Vaccines, with the following modifications.

Description Solid having the characteristic appearance of substances dried from frozen state. When reconstituted, it becomes a clear liquid that may be coloured owing to the presence of a pH indicator.

Stability The reconstituted solution of freeze-dried vaccine should be stored at a temperature between 2º and 8º protected from light. Discoloured or cloudy solutions should not be used. Discard unused reconstituted vaccines after 8 hours.

Strength available Not less than 1000 CCID₅₀ per 0.5 ml.

Dose Subcutaneous, preferably into the outer aspect of the upper arm, 0.5 ml. 

Contra-indication​

          1. It is contra-indicated in pregnant women; patients with a history of hypersensitivity reactions to this vaccine or any of its components; patients receiving immunosuppressive therapy; patients with blood dyscrasia, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; patients with primary or acquired immunodeficiency, or active untreated tuberculosis; patients with a family history of congenital or hereditary immunodeficiency.

2. Do not administer this vaccine during febrile respiratory illness or other active febrile infections.

          3. Do not vaccinate individuals who are immunosuppressed in association with AIDS or other clinical manifestations of infection with HIV, cellular immune deficiencies, and hypogammaglobulinemic and dysgammaglobulinemic states.

4. Defer immunization during the course of any acute illness.

Warning​

1. The administration of the vaccine less than one month before or after administration of other live viral vaccines should be avoided unless given simultaneously.

2. It may cause burning or stinging of short duration at the injection site.

          3. It should be used with caution in individuals with a history of febrile seizures, cerebral injury, or family histories of convulsions, or any other conditions in which fever-induced stress should be avoided.

4. It should be used with caution in individuals with a history of thrombocytopenic purpura or thrombocytopenia.

5. Delayed administration of the vaccine in an individual with a current or recent febrile illness depends largely on the severity and etiology of the illness.

Precaution​

1. Avoid pregnancy for 3 months following vaccination.

2. Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.

3. The immune status of patients about to undergo immunosuppressive therapy should be evaluated.

Additional information

1. Measles, mumps, and rubella vaccine are commercially available as a combination vaccine.

          2. The primary immunization against measles, mumps and rubella can be integrated with primary immunization against diphtheria, tetanus, pertussis, H. influenzae type b (Hib), hepatitis B, pneumococcal disease, poliomyelitis, and varicella.

3. The recommended age for primary vaccination is 9 to 12 months of age, followed by revaccination prior to elementary school entry.

4. It can be administered to people with minor illnesses such diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.

5. Children under treatment for tuberculosis may be immunized with the vaccine since no evidence of exacerbation of the disease has been reported.

          6. Vaccine originated from cell cultures of chick embryo or vaccine containing neomycin should be used with caution in persons with severe hypersensitive reactions caused by such antigens.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years after the date of the last satisfactory test for virus titre.

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 strain of measles virus used for the preparation of the vaccine; (2) the type and origin of the cells used for the preparation of the vaccine; (3) the minimum virus concentration contained in one recommended human dose; (4) that after reconstitution it should be used without delay or, if not used immediately, stored between 2º and 8º for a period not exceeding 8 hours; (5) that contact with disinfectants is to be avoided.

Identification When the reconstituted vaccine is mixed with an appropriate amount of specific measles antibodies, it is no longer able to infect susceptible cell cultures.

Bovine serum albumin Not more than 50 ng per single human dose. Carry out the “Immunochemical Methods” (Appendix 14.5).

Assay Titrate the vaccine for infective virus at least in triplicate, using at least five cell cultures for each 0.5 log10 dilution step or by a method of equal precision. Use an appropriate virus reference preparation to validate each assay. The estimated measles virus concentration is not less than that stated on the label; the minimum measles virus concentration stated on the label is not less than 1000 CCID₅₀ per single human dose (0.5 ml). The assay is not valid if the confidence interval (P = 0.95) of the logarithm of the virus concentration is more than ±0.3.

      National or International Reference Preparation of Live Measles Vaccine is suitable for use as a reference preparation.