Simultaneous administration of meningococcal C conjugate vaccine and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in children: a randomized double-blind study.

BACKGROUND: Meningococcal C disease can be life-threatening in infants, young children and adolescents. New conjugate vaccines are immunogenic in young infants and induce immunologic memory, so we should consider incorporating them into the routine childhood immunization program. The objective of this study was to measure the safety and immunogenicity of a meningococcal C conjugate vaccine when given with routine childhood vaccines.

METHODS: We carried out a randomized, double-blind, controlled clinical trial at children's hospitals in 3 Canadian cities. A convenience sample of 351 healthy 2-month-old infants was enrolled from the community and randomly allocated to receive either meningococcal C conjugate vaccine or the control (hepatitis B) vaccine. All participants received a concurrent injection of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine in the opposite limb. Participants were immunized at 2, 4, 6 and 15 months of age; adverse events were recorded after each dose. Serum bactericidal and ELISA meningococcal antibody levels in the participants were measured at 6, 7, 15 and 16 months of age; diphtheria, tetanus, H. influenzae type b, poliovirus and pertussis antibodies were measured at 7 months of age. A total of 323 (92%) participants completed all aspects of the study. The proportion of participants who suffered adverse events after each vaccine dose was the primary safety outcome. Geometric mean antibody titres and the proportion of participants with protective antibody levels after immunization were the primary immunologic outcomes.

RESULTS: After 2 doses of the meningococcal C conjugate vaccine 99% of participants achieved a protective ( > or = 1:8) bactericidal meningococcal serogroup C antibody level, and after 3 doses this rate increased to 100%. Antibody levels to the concomitant vaccine antigens in the group receiving meningococcal C vaccine were similar to those in the control group except for higher antidiphtheria antibody titres (p < 0.001). Local injection site reactions (redness and induration) after the meningococcal conjugate vaccine were more frequent than after hepatitis B vaccine but less frequent than after the DTaP-IPV-Hib vaccine.

CONCLUSIONS: The meningococcal C conjugate vaccine can be safely and effectively administered at the same visit as the other vaccine antigens routinely given to infants in Canada.