AIM OF THE STUDY: To evaluate the immunogenicity, safety and reactogenicity of a seven-valent pneumococcal conjugate vaccine (PCV7) when given concomitantly with a fully liquid DTaP-IPV-HBV-Hib combination vaccine. METHODS:Two hundred and sixty-six healthy infants in France (n=136) and Germany (n=130) were randomized to receive DTaP-IPV-HBV-Hib and PCV7 (test group) at the age of 2, 3 and 4 months (primary series) and 12-15 months (booster dose), or to receive DTaP-IPV-HBV-Hib at the same time points but PCV7 at the ages of 5, 6, 7 and 13-16 months (control group). Antibody levels to all vaccine antigens were measured before dose 1, 1 month after dose 3, at the time of booster, and 1 month later. Safety data were collected after each vaccine dose. RESULTS:Two hundred and fifty-seven infants (test group, 131; control group, 126) completed the primary immunization series and two hundred and forty-five received the booster dose (test group, 125; control group, 120). Depending on the serotype, 92.8-100% of subjects in the test group achieved antibody levels >or=0.15 microg/mL for PCV7 antigens at 5 months of age, and 89.7-99.1% of them antibody levels >or=0.50 microg/mL 1 month after booster. For DTaP-IPV-HBV-Hib, there was no statistically significant difference between the two groups in the proportion of infants that achieved pre-defined seroprotective levels for each antigen at 5 months and 1 month after booster. Frequency of local and systemic reactions was similar in both groups except for fever above 38.0 degrees C, which was more frequent in the test group after dose 1, 2 or 4. Fever >39.0 degrees C was only reported from three children in each group. CONCLUSION: The PCV7 vaccine was highly immunogenic, well tolerated, and safe when coadministered with the DTPa-IPV-HBV-Hib vaccine at 2, 3, and 4 months of age and a booster dose at 12-15 months. In this study, PCV7 did not show any relevant influence on the immunogenicity and safety of the concurrently administered DTPa-IPV-HBV-Hib vaccine.
RCT Entities:
AIM OF THE STUDY: To evaluate the immunogenicity, safety and reactogenicity of a seven-valent pneumococcal conjugate vaccine (PCV7) when given concomitantly with a fully liquid DTaP-IPV-HBV-Hib combination vaccine. METHODS: Two hundred and sixty-six healthy infants in France (n=136) and Germany (n=130) were randomized to receive DTaP-IPV-HBV-Hib and PCV7 (test group) at the age of 2, 3 and 4 months (primary series) and 12-15 months (booster dose), or to receive DTaP-IPV-HBV-Hib at the same time points but PCV7 at the ages of 5, 6, 7 and 13-16 months (control group). Antibody levels to all vaccine antigens were measured before dose 1, 1 month after dose 3, at the time of booster, and 1 month later. Safety data were collected after each vaccine dose. RESULTS: Two hundred and fifty-seven infants (test group, 131; control group, 126) completed the primary immunization series and two hundred and forty-five received the booster dose (test group, 125; control group, 120). Depending on the serotype, 92.8-100% of subjects in the test group achieved antibody levels >or=0.15 microg/mL for PCV7 antigens at 5 months of age, and 89.7-99.1% of them antibody levels >or=0.50 microg/mL 1 month after booster. For DTaP-IPV-HBV-Hib, there was no statistically significant difference between the two groups in the proportion of infants that achieved pre-defined seroprotective levels for each antigen at 5 months and 1 month after booster. Frequency of local and systemic reactions was similar in both groups except for fever above 38.0 degrees C, which was more frequent in the test group after dose 1, 2 or 4. Fever >39.0 degrees C was only reported from three children in each group. CONCLUSION: The PCV7 vaccine was highly immunogenic, well tolerated, and safe when coadministered with the DTPa-IPV-HBV-Hib vaccine at 2, 3, and 4 months of age and a booster dose at 12-15 months. In this study, PCV7 did not show any relevant influence on the immunogenicity and safety of the concurrently administered DTPa-IPV-HBV-Hib vaccine.
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