Journal article
A Randomized Trial to Assess Safety and Immunogenicity of Alternative Formulations of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine in Toddlers
J McVernon, T Nolan, P Richmond, G Reynolds, M Nissen, SB Lambert, H Marshall, T Papa, C Rehm
Pediatric Infectious Disease Journal | LIPPINCOTT WILLIAMS & WILKINS | Published : 2012
Abstract
BACKGROUND: Neisseria meningitidis is a leading cause of meningitis and septicemia globally. Recent shifts in serogroup dominance in some settings highlight the desirability of polysaccharide-conjugate vaccines with broader meningococcal coverage than serogroup C vaccines in widespread use. METHODS: We assessed the safety and immunogenicity of a single dose of meningococcal quadrivalent (A, C, W-135, Y) tetanus conjugate vaccine (TetraMen-T), administered at 1 year of age. A total of 378 children were randomized to 1 of 6 groups--5 received alternative formulations of TetraMen-T, the sixth licensed adjuvanted serogroup C conjugate vaccine (Neisvac-C). Solicited adverse event reports were col..
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Awarded by National Health and Medical Research Council
Funding Acknowledgements
J.M. (566635) and H.M. (1016272) supported by National Health and Medical Research Council Career Development Fellowships. The study was supported by Sanofi Pasteur. T.P. and C.R. are employees of Sanofi Pasteur. All other authors have acted as investigators on studies funded by Sanofi Pasteur and other vaccine manufacturers, through contractual arrangements with their respective institutions. J.M., T.N., P.R., G.R., M.N., S.L., and H.M. have received financial support from manufacturers to attend meetings and conferences to present scientific data. The authors have no other funding or conflicts of interest to disclose.