Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers

作者：Henry R. Shinefield, STEVEN B. BLACK, Paula Ray, Ih Chang, Ned Lewis, BRUCE H. FIREMAN, Jill G. Hackell, Peter R. Paradiso, George R. Siber, Robert C. Kohberger, Dace Viceps Madore, FRANK J. MALINOWSKI, ALAN E. KIMURA, Chinh Tri Le, IRENE LANDAW, JANET AGUILAR, John R. Hansen · 发表于：The Pediatric Infectious Disease Journal · 年份：1999 · DOI：10.1097/00006454-199909000-00004 · 被引用次数：272 · 研究领域：Pneumonia and Respiratory Infections、Bacterial Infections and Vaccines、Pharmacovigilance and Adverse Drug Reactions

OBJECTIVES: The objectives of this study were (1) to determine the safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate (PNCRM7) vaccine in infants and (2) to determine the effect of concurrent hepatitis B immunization during the primary series and the effect of concurrent diphtheria and tetanus toxoid and acellular pertussis [DTaP (ACEL-IMUNE)] and conjugate CRM197 Haemophilus influenzae type b [HbOC (HibTITER) immunization at time of the booster dose on the safety and immunogenicity of PNCRM7and these other concurrently administered vaccines. METHODS: This was a randomized double-blinded study in 302 healthy infants in the Northern California Kaiser Permanente (NCKP) Health Plan. Infants received either PNCRM7 vaccine or meningococcal group C conjugate vaccine as a control at 2, 4 and 6 months of age and a booster at 12 to 15 months of age. Study design permitted the evaluation of immunology and safety of concurrent administration of routine vaccines. Antibody titers were determined on blood samples drawn before and 1 month after the primary series and the booster dose. RESULTS: After the third dose of PNCRM7 geometric mean concentrations (GMCs) ranged from 1.01 for serotype 9V to 3.72 microg/ml for serotype 14. More than 90% of all subjects had a post-third dose titer of > or =0.15 microg/ml for all serotypes, and the percentage of infants with a post-third dose titer of > or =1.0 microg/ml ranged from 51% for type 9V to 89% for type 14. After the PNCRM7 ...