Clinical trial NCT02212457: Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Official title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal Group B Vaccine, in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 1063
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: OTHER

Brief summary: The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.


Eligibility criteria: Inclusion Criteria:

1. Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
2. Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
3. Female subjects of childbearing potential must have a negative urine preganancy test.

Exclusion Criteria:

1. Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
2. Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.

Primary outcomes:
measure: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.
timeFrame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)
Secondary outcomes:
measure: hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.
timeFrame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)
measure: Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.
timeFrame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)
measure: hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule.
timeFrame: At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)
measure: Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.
timeFrame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)
measure: hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.
timeFrame: At 1 month after last vaccination (Month 7)
measure: Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.
timeFrame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)
measure: Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule.
timeFrame: At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)
measure: hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules.
timeFrame: At Month 0, Month 2, Month 3, Month 7 and Month 13.
measure: Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules.
timeFrame: At Month 2, Month 3, Month 7 and Month 13
measure: The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains.
timeFrame: From Month 0 to Month 13
measure: Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination.
timeFrame: Within 30 minutes after vaccination
measure: Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination.
timeFrame: Within 30 minutes after vaccination
measure: Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination.
timeFrame: Day 1 through Day 30 after any vaccination
measure: Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
timeFrame: At Day 1 (6 hours) to Day 7 after vaccination
measure: Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
timeFrame: During the entire study period (Month 0 to Month 13)
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Augusta
country: United States
facility: GSK Investigational Site
state: Kansas
city: Niles
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Osielsko
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: