Authors
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GlaxoSmithKline Biologicals -More
Category
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Primary study
Registry of Trials»EU Clinical Trials Register
Year
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2016
INTERVENTION: Product Name: MenABCWY Pharmaceutical Form: Powder and suspension for suspension for injection CONDITION: Healthy volunteers (Immunisation against meningococcal infections) ; MedDRA version: 19.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] SECONDARY OUTCOME: Secondary end point(s): • hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ; • Percentages of subjects with hSBA titers = LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ; • Percentages of subjects with hSBA titers = 8 against N. meningitidis serogroups A, C, W and Y ; • Percentages of subjects with hSBA titers = 5 against serogroup B test strains. ; • Between‐group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ; • Within‐group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ; • Any unsolicited and solicited AEs reported ; • Solicited local (i.e., pain, erythema and induration) and systemic (i.e. chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature = 38°C (100.4°F)) ; • All unsolicited AEs reported ; • Medically‐attended AEs reported ; • AEs leading to premature withdrawal from the study ; • SAEs reported Timepoint(s) of evaluation of this end point: Day 1, 4, 8 and 31 for MenABCWY+OMV Group (A), MenACWY Group (B1) and MenACWY Group (B2). Day 1, 31, 34, 38 and 61 for Naive Group (C1) and Naive Group (C2). ; Day 1, 4, 8, 31, 34, 38, 61 ; Day 1, 4, 8, 31, 34, 38, 61 ; Day 1, 4, 8, 31, 34, 38, 61 ; Day 1, 4, 8, 31, 34, 38, 61 ; Day 4, 8, 31, 34, 38, 61 ; Within 30 min after vaccination ; From Day 1 (6 hrs) to Day 7 after each vaccination ; From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) ; During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) ; During the entire study period ; During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) INCLUSION CRITERIA: • Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1 (NCT01367158) study and who received no other meningococcal vaccines; Or • A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102_02 (NCT01210885) study and have not previously received any meningococcal vaccine. • Individuals who /whose parent(s)/legal guardian(s) have vol‐untarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. • Individuals who can comply with study procedures including blood draws and follow‐up. • Males Or • Females of non‐childbearing potential Or • Females of ch PRIMARY OUTCOME: Main Objective: • To assess antibody persistence against N. meningitidis serogroups (SP) A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, as measured by the percentage of subjects with hSBA titers = lower limit quantitation (LLQ) and other thresholds, hSBA Geometric Mean Titers (GMTs) and geometric mean ratios (GMRs).; • To evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in vaccine‐naïve subjects (VNS) of similar age, as measured by the percentage of subjects with hSBA titers =LLQ and other thresholds, hSBA GMTs and GMRs.; Primary end point(s): • Human Serum Bactericidal Assay (hSBA) Geometric Mean Ti‐ters (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • Percentages of subjects with hSBA titers = Lower Limit of Quantitation (LLQ) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • Percentages of subjects with hSBA titers = LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • Percentages of subjects with hSBA titers = 8 against N. meningitidis serogroups A, C, W and Y.; • Percentages of subjects with hSBA titers = 8 against N. meningitidis serogroups A, C, W and Y.; • Percentages of subjects with hSBA titers = 5 against serogroup B test strains.; • Percentages of subjects with hSBA titers = 5 against serogroup B test strains.; • Between‐group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • Between‐group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; • Within‐group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.; For MenABCWY+OMV Group, GMRs will be calculated with respect to the visit one month after the 2nd dose of MenABCWY+OMV in V102_02 (NCT02451514). For MenACWY Group, GMRs will be calculated with respect to the visit one month after the 1st dose of MenACWY in V102_02 (NCT02451514).; • Within‐group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. Secondary Objective: •To evaluate the safety & reactogenicity of the MenABCWY+OMV vaccine given as 1 or 2 doses in subjects previously vaccinated with MenABCWY+OMV or MenACWY & in VNSs; •To describe the kinetics of immune response following a dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY as measured by % of subjects with hSBA titers =LLQ & other thresholds, hSBA GMT & GMRs against SPs A,C,W &Y and SP B test strains at Day 1, 4, 8, and 31; •To describe the kinetics of immune response following 1 and 2 doses of MenABCWY+OMV in VNSs, as measured by % of subjects with hSBA titers = LLQ & other thresholds, hSBA GMT and CMRs against SPs A,C,W & Y & SP B test strains at Day 1, 31, 34, 38 & 61; •To assess immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY & VNSs, as measured by percentage of subjects with hSBA titers = LLQ & other thresholds, hSBA GMT & GMRs against SPs A, C, W and Y & SP B test strains at day 61 Timepoint(s) of evaluation of this end point: Day 1; Day 31; Day 1; Day 31; Day 1; Day 31; Day 1; Day 31; Day 1; Day 31; Day 1; Day 31
Epistemonikos ID: 63a9bc55f39c2d43cce0fe5169f0f2d296a8340f
First added on: Aug 24, 2024