Femme et Homme
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Extrait
•To demonstrate that GSK Biologicals’ DTPa IPV/Hib-MenC-TT vaccine co-administered with Prevenar (MenC-Combo group) is non-inferior to Pediacel co-administered with Prevenar and Menjugate (Control group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination. Criteria for non-inferiority: Non-inferiority in terms of response to PRP will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference (Control minus MenC-Combo group) in percentage of subjects with anti-PRP concentrations >= 0.15 micrograms/ml is <=10%. Non-inferiority in terms of response to MenC will be demonstrated if the upper limit of the 95% CI on the group difference (Control minus MenC-Combo group) in percentage of subjects with SBA-MenC titres >= 8 is <=10%.
Critère d'inclusion
- Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b (Hib), serogroup C meningococcal and Streptococcus pneumoniae diseases. Booster immunisation of healthy one-year-old children against Hib and serogroup C meningococcal diseases