Clinical Trial: Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2b Open-Label Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 Years After the Last Meningococcal Vaccination in Study V102_15 (NCT02212457) and the

Brief Summary: The purpose of this study is to compare the effectiveness of 2 (given at 0, 2 months) or 3 (given at 0, 2, 6 months) doses of the GSK MenABCWY vaccine administered to healthy adolescents in study V102_15 (NCT02212457), against a panel of randomly selected U.S. N. meningitidis serogroup B invasive disease strains at 24 months after the last meningococcal vaccination in V102_15 (NCT02212457) and response to a booster dose.

Detailed Summary:

Naive subjects will be randomized 1:1 to receive MenABCWY or rMenB+OMV at Day 1. No randomization to treatment arm for follow-on subjects is required as vaccine groups remain the same as in the parent study V102_15 (NCT02212457).

Response to a booster dose of MenABCWY vaccine will also be assessed in follow-on subjects who received 2 or 3 doses of MenABCWY (at 0.2-, 0,.6- or 0,.2,.6-month schedules) in the parent study, and will be compared with responses to a single dose of MenABCWY in naive subjects (subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study).

Response to a booster dose of GSK Meningococcal B Recombinant vaccine (rMenB+OMV) will be assessed in subjects who received 2 doses of rMenB+OMV (at 0, 2-month schedule) in the parent study, and will be compared with responses to a single dose of rMenB+OMV in naive subjects.


Sponsor: GlaxoSmithKline

Current Primary Outcome: Percentage of subjects without bactericidal serum activity at 1:4 dilution using enc-hSBA against each of the endemic US N. meningitidis serogroup B strains [ Time Frame: At 24 months after the last meningococcal vaccination in V102_15 (NCT02212457) i.e., Day 1 in this study ]

The percentages of subjects with 0, 2 and 0, 2, 6 treatment month schedule will be averaged across all strains for the ABCWY 0, 2 and 0, 2, 6 Groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Any solicited and unsolicited AEs reported within 30 minutes after vaccination [ Time Frame: At Day 1 (for all subjects) and also Day 61 (for naive subjects only) ]
  • Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination [ Time Frame: At Day 1 to Day 7 (for all subjects) and Day 61 to Day 67 (for naive subjects) ]
  • Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) within 7 days after vaccination [ Time Frame: At Day 1 (for all subjects) and Day 61 (for naive subjects) ]
  • Unsolicited AEs reported [ Time Frame: From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjects ]
  • Medically-attended AEs reported [ Time Frame: During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects) ]
  • AEs leading to premature withdrawal from the study [ Time Frame: During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects) ]
  • SAEs reported [ Time Frame: During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects) ]
  • Percentage of subjects without bactericidal serum activity at 1:4 dilution using enc-hSBA against each of the endemic US N. meningitidis serogroup B strains [ Time Frame: At Day 1 in the extension study ]
    The percentages of subjects will be averaged across all strains for the ABCWY 0, 2 and 0, 2, 6 Groups and the Naive Group
  • Percentages of subjects with exogenous human complement hSBA (HT-hSBA) titers ≥ Lower Limit of Quantitation (LLOQ) against each of four serogroup B test strains and serogroups A, C, W and Y [ Time Frame: At 24 months after last meningococcal vaccination for all follow-on subjects and at Day 1 in extension study for naive subjects ]
  • HT-hSBA GMTs against each of four serogroup B test strains and against N. meningitidis serogroups A, C, W and Y [ Time Frame: At 24 months after last meningococcal vaccination for all follow-on subjects and at Day 1 in extension study for naive subjects ]
  • Percentages of subjects with HT-hSBA titers ≥ LLOQ and differences between groups against each of four serogroup B test strains and serogroups A, C, W and Y (only after MenABCWY vaccination) [ Time Frame: Days 1, 6 and 31 for follow-on subjects Days 1, 31, 66 and 91 for naive subjects ]
  • HT-hSBA GMTs and group ratios against each of four serogroup B test strains and serogroups A, C, W and Y (only after MenABCWY vaccination), and GMRs [ Time Frame: Days 1 (except GMR), 6 and 31 for follow-on subjects Days 1, 31, 66 and 91 for naive subjects ]
  • Percentages of subjects with four-fold rise in HT-hSBA titers and group differences, against each of four serogroup B test strains1 and serogroups A, C, W and Y (only after MenABCWY vaccination) [ Time Frame: Days 1 (except four-fold rise), 6 and 31 for follow-on subjects Days 1, 31, 66 and 91 for naive subjects ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: October 25, 2016
Date Started: November 15, 2016
Date Completion: April 30, 2018
Last Updated: May 18, 2017
Last Verified: May 2017