Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.

Official Title
-----------------
A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea

Conditions
-----------------
Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ
* Biological: Placebo
* Biological: Meningococcal ACWY-CRM conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment; Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period); In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; With a negative urine pregnancy test (for female subjects only). Exclusion Criteria: History of any meningococcal vaccine administration; Current or previous, confirmed or suspected disease caused by N. meningitidis; Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; Pregnancy or nursing (breastfeeding) mothers; Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study; Any serious chronic or progressive disease; Family members and household members of research staff; Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives; Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment; Antibiotics within 6 days prior to enrollment; Known or suspected impairment/alteration of the immune system, immunosuppressive therapy; Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period; Participation in another clinical trial within the last 90 days or planned for during study.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rMenB<br>Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. | Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ<br>* Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.<br>|
| Active Comparator: Placebo/MenACWY<br>Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. | Biological: Placebo<br>* Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.<br>Biological: Meningococcal ACWY-CRM conjugate vaccine<br>* Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.<br>* Other names: Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group. | Day 1 and Day 61 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group. | Day 1 and Day 61 | 
| The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group. | Day 61/ Day 1 | 
| The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group. | Day 61 | 
| The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group. | Day 1 and Day 61 | 
| The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups. | The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group. | Day 61/Day 1 | 
| The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported. | Day 1 through day 7 after each vaccination | 
| The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported. | Day 1 through Day 61 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningitis, adolescents, Meningococcal B