Clinical Trial: A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-label, Controlled, Multi-center Extension Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who
Brief Summary: The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY
Detailed Summary: Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
- hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
- 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 [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ LLQ against N.meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 31 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 31 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 31 ]
- Between-group Geometric Mean Ratios (GMRs) comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
- Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
- Within-group GMRs
Original Primary Outcome:
- hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
- hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
- Percentages of subjects with hSBA titers ≥ LLQ against N.meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ LLQ against N.meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 31 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 31 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 31 ]
- Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
- Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
- Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and ser
Current Secondary Outcome:
- hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: 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). ]
- Percentages of subjects with hSBA titers ≥ LLQ against N. meningitides serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- 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. [ Time Frame: Day 4, 8, 31, 34, 38, 61 ]
- Any unsolicited and solicited AEs reported [ Time Frame: Within 30 minutes after vaccination ]
- 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)). [ Time Frame: From Day 1 (6 hours) to Day 7 after each vaccination ]
- All unsolicited AEs reported. [ Time Frame: 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) ]
- Medically-attended AEs reported [ Time Frame: 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) ]
- AEs leading to premature withdrawal from the study during the entire study period [ Time Frame: Day 1-61 ]
- AEs leading to premature withdrawal from the study [ Time Frame: 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) ]
- SAEs reported [ Time Frame: 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) ]
Original Secondary Outcome:
- hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Percentages of subjects with hSBA titers ≥ LLQ against N. meningitides serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- 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. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
- Any unsolicited and solicited AEs reported within 30 minutes after vaccination [ Time Frame: 30 minutes post vaccination ]
- 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)) AEs reported from Day 1 (6 hours) to Day 7 after each vaccination [ Time Frame: Day 1 (6 hours) to Day 7 after each vaccination ]
- All unsolicited AEs reported from Day 1 to Day 31 after each study vaccination [ Time Frame: Day 1-61 ]
- Medically-attended AEs reported during the entire study period [ Time Frame: Day 1-61 ]
- AEs leading to premature withdrawal from the study during the entire study period [ Time Frame: Day 1-61 ]
- SAEs reported during the entire study period [ Time Frame: Day 1-61 ]
Information By: GlaxoSmithKline
Dates:
Date Received: May 4, 2015
Date Started: June 2015
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017