Back to resultsSafety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Primary Purpose
Meningococcal Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meningococcal B Recombinant vaccine rMenB+OMV NZ
Placebo
Meningococcal ACWY-CRM conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningitis, adolescents, Meningococcal B
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.
Sites / Locations
- 06 Kosin University Gospel Hospital 34, amnam-dong
- 05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
- 04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
- 07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
- 01 Seoul National University Hospital 101 Daehang-ro,
- 03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
- 02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rMenB
Placebo/MenACWY
Arm Description
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01973218
First Posted
October 25, 2013
Last Updated
October 5, 2015
Sponsor
Novartis Vaccines
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01973218
Brief Title
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
Meningitis, adolescents, Meningococcal B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rMenB
Arm Type
Experimental
Arm Description
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.
Arm Title
Placebo/MenACWY
Arm Type
Active Comparator
Arm Description
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
Intervention Type
Biological
Intervention Name(s)
Meningococcal B Recombinant vaccine rMenB+OMV NZ
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACWY-CRM conjugate vaccine
Other Intervention Name(s)
Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
Description
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.
Time Frame
Day 1 and Day 61
Secondary Outcome Measure Information:
Title
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
Description
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.
Time Frame
Day 1 and Day 61
Title
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Description
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.
Time Frame
Day 61/ Day 1
Title
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Description
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.
Time Frame
Day 61
Title
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
Description
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.
Time Frame
Day 1 and Day 61
Title
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
Description
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.
Time Frame
Day 61/Day 1
Title
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Description
The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Time Frame
Day 1 through day 7 after each vaccination
Title
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Description
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.
Time Frame
Day 1 through Day 61
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
06 Kosin University Gospel Hospital 34, amnam-dong
City
Seo-gu
State/Province
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
City
Yangsan-si
State/Province
Gyeongnam
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
City
Bundang-gu
State/Province
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
01 Seoul National University Hospital 101 Daehang-ro,
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
110-744,
Country
Korea, Republic of
Facility Name
03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
City
Yangcheon-gu
State/Province
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26826544
Citation
Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
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