Persistence of antibody response at 5 years after one dose of MenACWY or Menomune®

• Conditions: ovartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005059-25-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines &Diagnostics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Written informed consent of the subject was obtained and documented or, in the case of unemancipated minors, written informed consent of the parent or guardian with written informed assent of the subject.
2. Individuals in good health as determined by
- medical history
- physical assessment
- clinical judgment of the investigator
3. Subjects between the ages of 16 and 23 years inclusive
4. For subjects in groups I and II only, receipt of either MenACWY or Menomune®.
5. A negative urine pregnancy test was required for female subjects
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Individuals' parents or legal guardians or individuals who were unable to comprehend or unwilling to follow all required study procedures for the whole period of the study.
2. History of documented invasive meningococcal disease.
3. Received any other meningococcal vaccine at any time outside of study V59P6.
4. Receipt of any vaccines in the 14 days preceding Visit 4 (Day 1) or expected receipt through the final blood draw at Visit 6 (Day 29).
5. Received antibiotic therapy within the 72 hours prior to collection of a blood sample.
6. Actively enrolled or scheduled to be enrolled in another clinical study during the planned period of this trial.
7. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
8. Individuals with suspected HIV infection or HIV related disease, or history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or receipt of immunosuppressive therapy within 6 months.
9. Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days.
10. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. Individuals who had any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
12. Acute medical illness with or without fever within 72 hours or an oral temperature=100.4°F (=38.0°C) at the time of inclusion.
13. Allergy to latex or items containing latex.
14. Administration of immune globulin or other blood products within the past 90 days.
15. Personal or family history of Guillain-Barré Syndrome.
16. Suspected or known hypersensitivity to any of the vaccine components.
17. Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
18. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
19. Individuals who were part of study personnel or close family members conducting this study.
20. Any condition which, in the opinion of the investigator, posed a health risk to the participant or rendered them inappropriate for a research study.

Study & Design

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