Immunogenicity, reactogenicity, and safety of a seven-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a fully liquid DTPa–IPV–HBV–Hib combination vaccine in healthy infants

Aim of the studyTo 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.MethodsTwo 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.ResultsTwo 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 ≥0.15 μg/mL for PCV7 antigens at 5 months of age, and 89.7–99.1% of them antibody levels ≥0.50 μg/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 °C, which was more frequent in the test group after dose 1, 2 or 4. Fever >39.0 °C was only reported from three children in each group.ConclusionThe 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.