[Study on safety and immunogenicity of oral poliomyelitis attenuated live vaccine (human diploid cell)].

OBJECTIVE

To evaluate the safety and Immunogenicity of the Poliomyelitis vaccine (Human Diploid Cell) in > or =2 month-old children.

METHODS

A random, blind and control trial, 1200 healthy children of 2-5 months old in Jiangsu province were administered OPV (HDC) vaccine and control vaccines. The antibody was tested by neutralization test.

RESULTS

After 3 doses of the OPV (HDC) vaccine, the systemic reactions were mild. After 1 month of vaccination with 3 doses of the OPV (HDC) vaccine, the immune success rates of I, II, III type were 98.28%, 99.45%, and 95.71% respectively, the GMTs of I, II, III type in susceptible children were 1:1243.72, 1:234.38 and 1:273.10 respectively.

CONCLUSIONS

The OPV (HDC) vaccine was safe and immunogenicity for the children > or =2 months old.