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Pharmacology: Pharmacodynamics: Four clinical studies provided results on the immune response with VIVAXIM. In total, 1090 subjects were included, with 179, 610, 243 and 58 subjects, respectively, in each study.
After primary vaccination, the seroprotection rate against the hepatitis A virus (HAV) (% ≥ 20 mIU/mL) was between 95.6% and 99.4% after 14 days and between 98.7% and 100% after 28 days.
The seroprotection rate against the Vi antigen (% ≥1 μg/mL) was between 83% and 89% after 14 days and between 69.8% and 91% after 28 days.
In one study, which evaluated the seroprotection rate for the Vi antigen observed 1, 2 or 3 years after the first dose of VIVAXIM and after revaccination with VIVAXIM at 3 years, the results were as follows: (see Table 1).
Click on icon to see table/diagram/imageSerological data show continuing protection against hepatitis A for up to 36 months in subjects who responded to the first dose of VIVAXIM. Seroprotection rates against the hepatitis A virus 1, 2 or 3 years after the first dose of VIVAXIM and after revaccination with VIVAXIM at 3 years, the results were as follows: (see Table 2).
Click on icon to see table/diagram/imageSimilar results were observed at the same dates in the control group, which received the monovalent typhoid Vi polysaccharide vaccine and the inactivated hepatitis A vaccine concomitantly.
In an open randomised study, the immunogenicity of the concomitant administration of VIVAXIM with the combined, adsorbed, tetanus, low dose diphtheria and inactivated poliomyelitis vaccine (Td-IPV) at two separate sites was compared to the separate administration at different time points in healthy adults. Seroconversion/seroprotection rates observed 28 days after vaccination in Per Protocol subjects were as follows: (see Table 3).
Click on icon to see table/diagram/imageNon-inferiority of the concomitant administration of VIVAXIM and Td-IPV vaccines compared to the separate administration was demonstrated for all the valences, except for the Vi valence.
For the Vi valence, the seroprotection rates (anti-Vi titres ≥ 1 μg/mL) increased from 7.5% in Group A and 7.1% in Group B at Day 0 to 86.3% and 94.8% respectively, 28 days after vaccination. In initially non-seroprotected subjects (anti-Vi titres < 1 μg/mL), seroconversion rates observed 28 days after vaccination were as follows: (see Table 4).
Click on icon to see table/diagram/imageIn initially non-seroprotected subjects, the anti-Vi seroconversion rate (≥ 4-fold rise) for concomitant vaccines administration was non-inferior to the separate administration.
Paediatric population: No data on the efficacy of VIVAXIM in children and adolescents below 16 years are available.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Non-clinical data obtained with the monovalent vaccines contained within this vaccine combined vaccine, reveal no special hazard for humans based on single, repeated dose and local tolerance toxicity studies.
