Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

• Conditions: Prophylaxis Aganist Invasive Meningococcal Disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004734-25-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-11
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. male and female adolescents 11 through 18 years of age at enrollment;
2. able to comprehend and follow all required study procedures (i.e., able to give blood for analysis of safety and immunogenicity);
3. who had given written assent and for whom the parent or legal guardian had provided written informed consent after the nature of the study had been explained;
4. who, with their parent or guardian as required, were available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
5. in good health as determined by the outcome of medical history, physical examination, screening laboratory tests and clinical judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. had a history of any meningococcal B vaccine administration;
2. had a current or previous, confirmed or suspected disease caused by N. meningitidis;
3. had had household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. had experienced fever (defined as oral temperature = 38.0°C [100.4°F]) within the previous 3 days or were suffering from a current acute infection;
5. had taken antibiotics within 7 days prior to enrollment (exception: Azithromycin or once daily antibiotics within 14 days prior to enrollment);
6. were pregnant or nursing mothers or females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12-month duration of the study. Abstinence, oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control. If sexually active the subject had to have used one of the accepted birth control methods at least two months prior to study enrollment;
7. had any serious chronic or progressive disease (e.g., any history of neoplasm, diabetes, cardiac disease, hepatic disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment.) Subjects with moderate or severe asthma requiring chronic use of inhaled or systemic corticosteroids were not eligible for enrollment);
8. had any other serious chronic disease including progressive neurological disease or seizure disorder;
9. had a known or suspected disease of the immune system, or were receiving immunosuppressive therapy, including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 60 days;
10. had an inherited genetic anomaly (e.g., Down's Syndrome);
11. had received blood, blood products or a parenteral immunoglobulin preparation within the previous 60 days;
12. had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
13. had a history of severe allergic reactions after previous vaccinations, such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component;
14. had either received, or for whom there was intent to immunize with any other vaccine(s) within 30 days prior, through 30 days following, study injection (Exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment);
15. had any condition which in the opinion of the investigator and/or the medical monitor may interfere with the evaluation of the study objectives;
16. had received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study;
17. were currently receiving or had received Accutane (Isotretinoin) in the previous 14 days.
18. had a current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified