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

Not Applicable

Completed

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0001103
• Lead Sponsor: ovartis Korea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Individuals eligible to be enrolled into this study are male and female subjects:
1.11-17 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;
1.Who are available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
2.In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
3.With a negative urine pregnancy test (for female subjects only).

Exclusion Criteria

Exclusion Criteria
In order to participate in this study, all subjects must meet NONE of the exclusion criteria described below:
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. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
6.Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
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(for example requiring systemic antibiotic treatment or antiviral therapy) or fever (defined as axillary temperature 38degrees centrigrade over) 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, including use of corticosteroids in immunosuppressive doses (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrolment) or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; use of immunostimulants (e.g. IL-2, IFN-a, Imiquimod) within the previous 90 days;
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 (60 days for live viral vaccines) and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw for last visit);
15. Participation in another clinical trial within the last 90 days or planned for during study;
There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for study enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified