Solicited adverse events were either measured (fever, erythema, s

Solicited adverse events were either measured (fever, erythema, swelling) or categorized by the parents as mild (no limitation of normal daily activities), moderate (some limitation of normal daily activities) or severe (unable to perform normal daily activities). Medically significant events, such as hospitalizations, and other serious adverse events were collected for six months following vaccination. All unsolicited adverse

events were collected and tabulated by preferred term and body system. Blood was collected by venipuncture immediately before and approximately 28 days after vaccination (after the second dose in the two-dose group). Functional antibody to each of the four meningococcal groups was measured by a serum bactericidal assay using human complement GSK1349572 chemical structure (hSBA) and reported as reciprocal dilution (RD) [21], [25] and [26]. All antibody measurements were performed by Novartis Vaccines and Diagnostics (Marburg, Germany). The primary objective of the study was to compare

the immunogenicity of a single dose of MenACWY-CRM with a single dose of MCV4 in children 2–5 years of age and children 6–10 years of age. Immunogenicity was characterized as the percentage of subjects achieving a seroresponse against each of the four groups (A, C, W and Y). Seroresponse was defined as a four fold or greater INK 128 mouse rise in group-specific antibody; in participants with a prevaccination antibody titer <4, seroresponse was defined as an hSBA of ≥8. Secondary objectives included Vasopressin Receptor evaluation of the geometric mean hSBA antibody titers (hSBA GMTs) and the proportion of participants achieving hSBA titers ≥8 (seroprotection). Additional secondary objectives were to assess the safety and tolerability of all the vaccines administered and to

assess the immunogenicity (as defined by all of the above immunogenicity parameters) of two doses of MenACWY-CRM in children 2–5 years of age. All subjects who received at least one dose of vaccine were included in the safety analysis. Adverse events were tabulated and the maximum severity reported for each time period was used. The proportion of participants having an adverse event by vaccine group was calculated with 95% confidence intervals (CIs). All subjects who received all the protocol-specified doses of vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to database lock and unblinding were part of the per-protocol immunogenicity analysis population. A major protocol violation was defined as one that was considered to have a significant impact on the immunogenicity results of the subject.

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