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

NCT ID: NCT01973218

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

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.

Conditions

Meningococcal Disease

Keywords

Meningitis, adolescents, Meningococcal B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

rMenB

Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.

Group Type: EXPERIMENTAL

Meningococcal B Recombinant vaccine rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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/MenACWY

Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

06 Kosin University Gospel Hospital 34, amnam-dong

Seo-gu, Busan, South Korea

05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu

Ansan-si, Gyeonggi-do, South Korea

04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup

Yangsan, Gyeongsangnam-do, South Korea

07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil

Bundang-gu, Seongnam, South Korea

01 Seoul National University Hospital 101 Daehang-ro,

Jongno-gu, Seoul, South Korea

03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong

Yangch’ŏn-gu, Seoul, South Korea

02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu

Incheon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26826544 (View on PubMed)

Other Identifiers

20130090378

Identifier Type: OTHER

Identifier Source: secondary_id

V72_42

Identifier Type: -

Identifier Source: org_study_id