Immunogenicity of a Tetravalent Meningococcal Glycoconjugate Vaccine in Infants

Snape, Matthew D.; Perrett, Kirsten P.; Ford, Karen; John, Tessa M.; Pace, David; Yu, Ly-Mee; Langley, Joanne M.; McNeil, Shelly; Dull, Peter; Ceddia, Francesca; Anemona, Alessandra; Halperin, Scott A.; Dobson, Simon; Pollard, Andrew J.

doi:10.1001/jama.2007.29-c

Cited by 199 publications

(121 citation statements)

References 12 publications

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“…Immune responses to N. meningitidis serogroup Y were assessed using the conventional hSBA assay. 14 The hSBA antibody responses against meningococcal serogroups ACWY were expressed as the percentage of subjects with seroresponse, percentage of subjects with hSBA titers 8, and hSBA geometric mean titers (GMTs) (see Table 4 for additional information on the serogroup A, C, W, and Y test strains). Seroresponse was defined as the percentage of subjects per group achieving at least a 4-fold increase in titers from a prevaccination titer 4 or a rise to 8 in those with a prevaccination titer <4.…”

Section: Immunogenicity Analysesmentioning

confidence: 99%

“…[11][12][13] The results of clinical evaluations of MenACWY-CRM (Menveo Ò , Novartis Vaccines, Siena, Italy), a quadrivalent meningococcal oligosaccharide-CRM 197 conjugate vaccine, 9 demonstrate that this vaccine is highly immunogenic and well tolerated in a wide range of age populations beginning from 2 months of age. [14][15][16] MenACWY-CRM is currently licensed for use in children, adolescents and adults in many countries, including the US and countries in the EU, Latin America and Asia.…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

Sáez-Llorens

Vaca²,

Abarca

et al. 2015

Human Vaccines & Immunotherapeutics

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This phase 2 study assessed the immunogenicity, safety, and reactogenicity of investigational formulations of meningococcal ABCWY vaccines, consisting of recombinant proteins (rMenB) and outer membrane vesicle (OMV) components of a licensed serogroup B vaccine, combined with components of a licensed quadrivalent meningococcal glycoconjugate vaccine (MenACWY-CRM). A total of 495 healthy adolescents were randomized to 6 groups to receive 2 doses (Months 0, 2) of one of 4 formulations of rMenB antigens, with or without OMV, combined with MenACWY-CRM, or 2 doses of rMenB alone or one dose of MenACWY-CRM then a placebo. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroups ACWY and serogroup B test strains; solicited reactions and any adverse events (AEs) were assessed. Two MenABCWY vaccinations elicited robust ACWY immune responses, with higher seroresponse rates than one dose of MenACWY-CRM. Bactericidal antibody responses against the rMenB antigens and OMV components were highest in subjects who received 2 doses of OMV-containing MenABCWY formulations, with 68% of subjects achieving hSBA titers 5 against each of the serogroup B test strains. After the first dose, solicited local reaction rates were higher in the MenABCWY or rMenB groups than the MenACWY-CRM group, but similar across groups after the second dose, consisting mainly of transient injection site pain. Fever ( 38.0 C) was rare and there were no vaccine-related serious AEs. In conclusion, investigational MenABCWY formulations containing OMV components elicited highly immunogenic responses against meningococcal serogroups ACWY, as well as serogroup B test strains, with an acceptable safety profile. [NCT01210885]

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Section: Immunogenicity Analysesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

Sáez-Llorens

Vaca²,

Abarca

et al. 2015

Human Vaccines & Immunotherapeutics

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“…There was little indication that the relationship between the imputation and analytic models was recognized in the papers reviewed. Three RCTs [14][15][16] reported using an approach that would accommodate the possibility of an interaction. All of these trials imputed data separately in each arm of the trial.…”

Section: Implementation and Imputation Modelmentioning

confidence: 99%

The use and reporting of multiple imputation in medical research – a review

Mackinnon

2010

Journal of Internal Medicine

176

144

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“…Food and Drug Administration for asplenic patients age 56 years or more, 78,79 patients who have undergone splenectomy-even those age 56 years or moreshould receive the quadrivalent conjugate meningococcal vaccine. 80 This recommendation is supported by data showing that in individuals who previously received a meningococcal conjugate vaccine, antibody responses to a subsequent dose of the same vaccine were higher than those to a subsequent dose of the polysaccharide quadrivalent vaccine. 81 Two new serogroup B meningococcal vaccines (Bexsero, Novartis, USA, and Trumenba, Pfizer, USA) that have been approved recently by the US.…”

Section: Meningococcal Vaccinementioning

confidence: 94%