The safety, reactogenicity and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) concurrently administered with a combination DTaP-IPV-Hib vaccine.

To evaluate immune responses, safety and reactogenicity of the concomitant use of DTaP-IPV-Hib and the newly available 7-valent pneumococcal conjugate (7VPnC) vaccines when given as the primary immunization series in early infancy. A total of 231 healthy infants were enrolled at 11 German study centers and randomized to receive either 7VPnC plus DTaP-IPV-Hib vaccines concomitantly into opposite limbs at age 2, 3, 4 and 11-15 months (7VPnC group) or DTaP-IPV-Hib vaccine at the same ages plus a 7VPnC "catch-up vaccination" at ages 6, 7, 8 and 11-15 months (Control group). Blood samples were drawn before and 4 weeks after the first three vaccine doses and 4 weeks after the fourth dose. Local and general side effects (i.e. safety) were solicited by diary cards. Immune responses were determined by ELISA except for antibodies to polioviruses (neutralization assay). Post-dose 3, a significant antibody response against all seven pneumococcal vaccine-serotypes was observed in the 7VPnC group only. Post-dose 4 geometric mean concentrations (GMCs) were similar in both groups. GMCs for other vaccine antigens were comparable between groups except for diphtheria (higher in the 7VPnC group) and pertactin (lower in the 7VPnC group), although after three vaccine doses there was a 28-fold rise in GMCs from baseline. Both vaccines were generally well-tolerated although there were minor differences in the frequency of local reactions and somewhat more fever or drowsiness in the 7VPnC group. The use of DTaP-IPV-Hib and the 7VPnC vaccine was safe, well-tolerated and immunogenic when given concomitantly at age 2, 3 and 4 months or when given separately with 7VPnC as a catch-up vaccination at age 6, 7, 8 months and as a concomitant booster immunization at age 11-15 months.

RCT Entities:   Population Interventions Outcomes