The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B. The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. Hexaxim is a whitish, cloudy suspension. PHARMACOLOGY Mechanism of action Hexaxim induces the production of antibodies against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. CLINICAL TRIALS The primary vaccination schedules that have been used are: 6, 10, 14 weeks with and without hepatitis B vaccination at birth; 2, 3, 4 months without hepatitis B vaccination at birth; 2, 4, 6 months with and without hepatitis B vaccination at birth. Results obtained in the clinical studies for each of the components are summarised in the tables below: Table 2: Percentage of individuals with antibody titres seroprotection/seroconversion rates* one month after primary vaccination with Hexaxim 2-4-6 6-10-14 2-3-4 Antibody titres seroprotection/seroconversion Months Weeks Months rates N†=934 to N†=123 to 220 N†=145 1270 % % % Anti-diphtheria 97.6 99.3 97.1 ( 0.01 IU/ml) Anti-tetanus 100.0 100.0 100.0 ( 0.01 IU/ml) Anti-PT 93.6 93.6 96 ( 4 fold rise) Anti-FHA 93.1 81.9 97.0 ( 4 fold rise) With hepatitis B 99.0 / 99.7 Anti-HBs vaccination at birth ( 10 mIU/ml) Without hepatitis B 95.7 94.0 98.8 vaccination at birth type 1 100.0 97.7 99.9 ( 8 (1/dilution))
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B. The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. Hexaxim is a whitish, cloudy suspension. PHARMACOLOGY Mechanism of action Hexaxim induces the production of antibodies against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. CLINICAL TRIALS The primary vaccination schedules that have been used are: 6, 10, 14 weeks with and without hepatitis B vaccination at birth; 2, 3, 4 months without hepatitis B vaccination at birth; 2, 4, 6 months with and without hepatitis B vaccination at birth. Results obtained in the clinical studies for each of the components are summarised in the tables below: Table 2: Percentage of individuals with antibody titres seroprotection/seroconversion rates* one month after primary vaccination with Hexaxim Antibody titres seroprotection/seroconversion rates 6-10-14 Weeks N†=123 to 220 2-3-4 Months N†=145 2-4-6 Months N†=934 to 1270 % % % Anti-diphtheria ( 0.01 IU/ml) 97.6 99.3 97.1 Anti-tetanus ( 0.01 IU/ml) 100.0 100.0 100.0 Anti-PT ( 4 fold rise) 93.6 93.6 96 Anti-FHA ( 4 fold rise) 93.1 81.9 97.0 Anti-HBs ( 10 mIU/ml) With hepatitis B vaccination at birth 99.0 / 99.7 Without hepatitis B vaccination at birth 95.7 94.0 98.8 type 1 ( 8 (1/dilution)) 100.0 97.7 99.9
auspar-dtpa-150112-pi.docx