Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study.

A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by ≥ 15 days; staggered group). DTaP(5)-IPV/Hib was administered at 2, 4, 6, and 15 months of age, and PCV7 was administered concurrently or at 3, 5, 7, and 16 months of age. The study results found that DTaP(5)-IPV/Hib is safe and immunogenic when given concurrently with 7-valent pneumococcal conjugate vaccine.

RCT Entities:   Population Interventions Outcomes