Clinical Trial: Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescent
Brief Summary: Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: The 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: 1month after the 2-dose vaccination series. ]
Original Primary Outcome:
- Percentages of N. meningitidis serogroup B invasive disease strains killed at 1:4 and 1:8 dilutions, for each subject [ Time Frame: 1 Month after 2-Dose vaccination Series ]
- Percentages of N. meningitidis serogroup B invasive disease strains killed at 1:4 and 1:8 dilutions, for each subject [ Time Frame: 4 Months after 2-dose Vaccination Series ]
- percentages of subjects with hSBA ≥ 1:4 and hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains [ Time Frame: 1 Month after 2-Dose vaccination Series ]
- percentages of subjects with hSBA ≥ 1:4 and hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains [ Time Frame: 4 Months after 2-Dose Vaccination Series ]
- percentages of subjects with hSBA titers against serogroup B test strains ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 [ Time Frame: one month after 2-dose vaccination series ]
- percentages of subjects with hSBA titers against serogroup B test strains ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 [ Time Frame: four Months after 2-dose vaccination series ]
Current Secondary Outcome:
- percentages of N. meningitidis serogroup B invasive disease strains killed at 1:4 and 1:8 dilutions after the 2-dose vaccination series [ Time Frame: 1 Month ]
- percentages of N. meningitidis serogroup B invasive disease strains killed at 1:4 and 1:8 dilutions after the 2-dose vaccination series [ Time Frame: 4 Months ]
- percentages of subjects with hSBA ≥ 1:4 and hSBA titer ≥ 1:8 against 4 N. meningitidis serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- percentages of subjects with hSBA ≥ 1:4 and hSBA titer ≥ 1:8 against 4 N. meningitidis serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- percentages of subjects with hSBA titers against 4 serogroup B test strains ≥LLQ after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- percentages of subjects with hSBA titers against 4 serogroup B test strains ≥LLQ after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- percentages of subjects with four-fold rise in hSBA titer against 4 serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- percentages of subjects with four-fold rise in hSBA titer against 4 serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- hSBA GMTs against 4 serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- hSBA GMTs against 4 serogroup B test strains after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W, and Y after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W, and Y after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- percentages of subjects with four-fold rise in hSBA titer against serogroups A, C, W and Y after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- percentages of subjects with four-fold rise in hSBA titer against serogroups A, C, W and Y after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- hSBA GMTs to serogroups A, C, W, and Y after the 2-dose vaccination series. [ Time Frame: 1 Month ]
- hSBA GMTs to serogroups A, C, W, and Y after the 2-dose vaccination series. [ Time Frame: 4 Months ]
- Adverse Events [ Time Frame: 1 to 6 months ]
Original Secondary Outcome:
- Adverse events and other indicators of reactogenicity [ Time Frame: Day 1 to 6 months. ]
- percentages of subjects with two-, three- and four-fold rise in hSBA titer against serogroup B test strains [ Time Frame: one month after 2-dose vaccination series ]
- percentages of subjects with two-, three- and four-fold rise in hSBA titer against serogroup B test strains [ Time Frame: Four months after 2-dose vaccination series ]
- hSBA Geometric Mean Titers against serogroup B test strains [ Time Frame: one month after 2-dose vaccination series ]
- hSBA Geometric Mean Titers against serogroup B test strains [ Time Frame: Four months after 2-dose vaccination series ]
- percentages of subjects with hSBA titers ≥ LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against serogroups A, C, W, Y [ Time Frame: one month after 2-dose vaccination series ]
- percentages of subjects with hSBA titers ≥ LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against serogroups A, C, W, Y [ Time Frame: Four Months after 2-Dose vaccination series ]
- percentages of subjects with two-, three- and four-fold rise in hSBA titer against serogroups A, C, W and Y [ Time Frame: One month after 2-dose vaccination series ]
- percentages of subjects with two-, three- and four-fold rise in hSBA titer against serogroups A, C, W and Y [ Time Frame: Four months after 2-Dose vaccination Series ]
- hSBA Geometric Mean Titers to serogroups A, C, W, and Y [ Time Frame: One month after 2-dose vaccination series ]
- hSBA Geometric Mean Titers to serogroups A, C, W, and Y [ Time Frame: Four Months after 2-dose vaccination series ]
Information By: Novartis
Dates:
Date Received: May 6, 2014
Date Started: May 2014
Date Completion:
Last Updated: April 17, 2015
Last Verified: April 2015