Clinical trial NCT02140762: Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
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 Adolescents in the U.S.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Meningitis ABCWY
Adolescents
Vaccination
Meningococcal disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-05-16
Enrollment: 305
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.


Eligibility criteria: Inclusion Criteria:

* Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
* Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

* Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
* Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Primary outcomes:
measure: Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.
timeFrame: One month after the second vaccination (month 3)
Secondary outcomes:
measure: Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination
timeFrame: One month after the second vaccination (month 3)
measure: Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
timeFrame: Baseline, one month after second vaccination (month 3)
measure: Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
timeFrame: Baseline, four months after second vaccination (month 6)
measure: Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
timeFrame: One month after the second vaccination (month 3)
measure: Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
timeFrame: Four months after the second vaccination (month 6)
measure: hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
timeFrame: One month after the second vaccination (month 3)
measure: HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
timeFrame: Four months after the second vaccination (month 6)
measure: hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
timeFrame: One month after the second vaccination (month 3)
measure: HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
timeFrame: At baseline(day 1) and One month after the second vaccination (month 3)
measure: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
timeFrame: At Baseline and One month after the second vaccination (month 3)
measure: Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
timeFrame: Four months after the second vaccination (month 6)
measure: Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
timeFrame: One month after the second vaccination (month 3)
measure: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
timeFrame: One month after the second vaccination (month 3)
measure: Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
measure: Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
measure: Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
measure: Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
measure: Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)
measure: Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
timeFrame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: From day 1 (6 hours) until day 7 after any vaccination
measure: Number of Subjects Reporting Unsolicited AEs.
timeFrame: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Accelovance, Inc
state: Alabama
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Melbourne
country: United States
facility: Accelovance, Inc
state: Florida
city: Newton
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Cleveland
country: United States
facility: Senders Pediatrics
state: Ohio
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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citation: Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26.
citation: Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
citation: Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.