Reactogenecity of indigenously produced measles vaccine.

OBJECTIVE: To assess the safety and reactogenecity of indigenously produced measles vaccine derived from EZ strain. DESIGN: A longitudinal clinical follow up after vaccination. SETTING: Hospital based and home follow up, as required. SUBJECTS: 12,470 children, 9 to 15 months old, immunized with measles vaccine of EZ strain, in accordance with the National Immunization Schedule, at five centers. METHODS: A clinical follow up of children at 1 day, 1 week, 2 weeks, 3 weeks and 6 weeks after measles vaccination. A detailed clinical neurological examination in children showing side effects. RESULTS: Mild side effects were documented in 31%. Of these, 90% were seen in the first two weeks, out of which two thirds were seen during the first week. Commonest side effects were coryza (10%), fever (9.8%), cough (3.2%) and diarrhea (3.2%). Convulsions, with no later sequelae were documented in 2 cases only. CONCLUSIONS: Measles vaccine manufactured in India, using EZ strain is a safe vaccine. It has a level of reactogenecity including neurological aspects, lower than that reported in India with the Schwarz strain vaccine.

Immunogenicity and reactogenicity of indigenously produced MMR vaccine.

OBJECTIVES: To study immunogenicity and reactogenicity of indigenously produced MMR vaccine and to assess the booster effect of MMR immunization on measles seroconversion. DESIGN: A longitudinal follow up. SETTING: Hospital based and home follow up, as required. SUBJECTS: 89 children already immunized for measles, between 15 to 24 months of age for immunogenic evaluation and 866 subjects for the reactogenic component. METHODS: Prevaccination and postvaccination samples collected one and four weeks after vaccination were studied by ELISA for IgG and IgM antibodies against the three diseases. A clinical follow up of immunized children was done at 3 days, 7 days, 6 weeks and 6 months after immunization. RESULTS: IgG positivity 4 weeks after immunization rose from 75% to 100% for measles, from 12% to 92% for mumps, and from 13% to 99% for rubella. Only mild side effects including pain and swelling in 37 (4.3%) cases, mild fever in 51 (5.9%) cases, cough in 40 (4.6%) cases and a transient rash in 7 (0.8%) cases were observed. CONCLUSIONS: The indigenously manufactured MMR vaccine has an excellent immunogenicity and low reactogenicity with a booster effect for measles seroconversion in children already immunized for this disease.