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https://hdl.handle.net/2440/70114
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dc.contributor.author | McVernon, J. | - |
dc.contributor.author | Nolan, T. | - |
dc.contributor.author | Richmond, P. | - |
dc.contributor.author | Reynolds, G. | - |
dc.contributor.author | Nissen, M. | - |
dc.contributor.author | Lambert, S. | - |
dc.contributor.author | Marshall, H. | - |
dc.contributor.author | Papa, T. | - |
dc.contributor.author | Rehm, C. | - |
dc.date.issued | 2012 | - |
dc.identifier.citation | The Pediatric Infectious Disease Journal, 2012; 31(1):E15-E23 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.issn | 1532-0987 | - |
dc.identifier.uri | http://hdl.handle.net/2440/70114 | - |
dc.description.abstract | <h4>Background</h4>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.<h4>Methods</h4>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 collected from day 0 to 7 after vaccination and unsolicited and serious adverse event reports throughout study participation. Immunogenicity was assessed by serum bactericidal assays containing either a human (hSBA) or baby rabbit (rSBA) complement source before and 1 month after immunization.<h4>Results</h4>All vaccine formulations were safe and well tolerated. Using the various measures of immunogenicity, no consistent relationships were observed between the dose of either polysaccharide or carrier and serogroup-specific response for any one antigen. The highest-dose vaccine provided optimal coverage for all 4 serogroups, with the percentage of recipients achieving hSBA titers ≥ 8 against each as follows: A, 92%; C, 96%; W-135, 71%; Y, 82% (corresponding proportions with rSBAs titers >8 all exceeded 90%). The investigational vaccines were less immunogenic against the serogroup C capsular polysaccharide than the licensed comparator.<h4>Conclusions</h4>Studies are ongoing that will help to identify optimal scheduling of quadrivalent meningococcal conjugate vaccines, to facilitate their inclusion into national immunization programs seeking extended serogroup coverage against meningococci. | - |
dc.description.statementofresponsibility | Jodie McVernon, Terry Nolan, Peter Richmond, Graham Reynolds, Michael Nissen, Stephen B. Lambert, Helen Marshall, Thomas Papa and Christine Rehm | - |
dc.language.iso | en | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.rights | © 2012 Lippincott Williams & Wilkins, Inc. | - |
dc.source.uri | http://www.ncbi.nlm.nih.gov/pubmed/22094636 | - |
dc.subject | vaccines | - |
dc.subject | meningococcal | - |
dc.subject | tetravalent meningococcal vaccine | - |
dc.subject | randomized controlled trial | - |
dc.subject | infant | - |
dc.title | 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 | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1097/INF.0b013e31823e1e34 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/566635 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/1016272 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Marshall, H. [0000-0003-2521-5166] | - |
Appears in Collections: | Aurora harvest Paediatrics publications |
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