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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973218
• Other study ID #: V72_42
• Secondary ID: 20130090378
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2013
• Last updated: October 5, 2015
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 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;

2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);

3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;

4. With a negative urine pregnancy test (for female subjects only).

Exclusion Criteria:

1. History of any meningococcal vaccine administration;

2. Current or previous, confirmed or suspected disease caused by N. meningitidis;

3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;

4. Pregnancy or nursing (breastfeeding) mothers;

5. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;

6. Any serious chronic or progressive disease;

7. Family members and household members of research staff;

8. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;

9. Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;

10. Antibiotics within 6 days prior to enrollment;

11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;

12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;

13. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;

14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;

15. Participation in another clinical trial within the last 90 days or planned for during study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Meningococcal B Recombinant vaccine rMenB+OMV NZ
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.
• Placebo
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.
• Meningococcal ACWY-CRM conjugate vaccine
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.

Locations

Country	Name	City	State
Korea, Republic of	05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu	Ansan-si	Gyeonggi-do
Korea, Republic of	07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil	Bundang-gu	Seongnam
Korea, Republic of	02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu	Incheon
Korea, Republic of	01 Seoul National University Hospital 101 Daehang-ro,	Jongno-gu	Seoul
Korea, Republic of	06 Kosin University Gospel Hospital 34, amnam-dong	Seo-gu	Busan
Korea, Republic of	03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong	Yangcheon-gu	Seoul
Korea, Republic of	04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup	Yangsan-si	Gyeongnam

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No