[The results of the registration clinical trials of the Act-Hib vaccine manufactured by the firm of Pasteur Mérieux Connaught, France].
The results of the field trials of the vaccine "Act-Hib" against Haemophilus influenzae of type b, presented for registration by Pasteur Mérieux Connaught (France), are summarized. The vaccine was found to have low reactogenicity and high immunological effectiveness. A single injection of the vaccine induced the formation of the protective level of anti-PRP antibodies in 94% of the immunized children aged 1-4 years. After immunization the mean geometric titers of specific antibodies increased sixfold in comparison with the initial level and were equal to 3.4 mu/ml. On the basis of the data of laboratory control and field clinical trials the vaccine "Act-Hib" was registered in the Russian Federation and permission and its practical use in the public health service of the country was permitted.
Gorbunov
M A
MA
Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.
Pavlova
L I
LI
Chuprinina
R P
RP
Nemirovskaia
T I
TI
D000907:Antibodies, Bacterial / Q000097:blood; D000918:Antibody Specificity; D000942:Antigens, Bacterial / Q000276:immunology; D002675:Child, Preschool; D017277:Drug Approval; D005602:France; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006193:Haemophilus influenzae / Q000276:immunology; D006801:Humans; D007223:Infant; D012426:Russia; D013997:Time Factors
D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D018073:Haemophilus Vaccines