Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

• Conditions: Prophylaxis against invasive meningococcal disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004992-21-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-28
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1775

Inclusion Criteria

Inclusion criteria for naive subjects, newly enrolled:
1. Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).
2. For minor subjects:
- Subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.
For adult subjects:
- Subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
3. Were available for the visit scheduled in the study.
4. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
1. For minor subjects: (= 18 years of age) Subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of
the study had been explained.
For adult subjects: (older than 18 years of age)
Subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
2. Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1.
3. Who had completed the vaccination course in study V72P10, according to the protocol.
4. Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol.
5. Were available for the study visit scheduled in the study.
6. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 817
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

Exclusion criteria for naive subjects newly enrolled:
1. For minor subjects:
- Subjects who were unwilling or unable to give written informed assent to participate in the study, and whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study.
For adult subjects:
- Subjects who were unwilling or unable to give written informed consent to participate in the study.
2. History of any meningococcal B vaccine administration.
3. Previous ascertained or suspected disease caused by N. meningitidis.
4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
5. Antibiotic treatment within 6 days prior to enrollment.
6. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
7. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion).
8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
9. Participation in another clinical trial within 90 days prior to enrollment or planned for during study.
10. Family members and household members of study staff.
11. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Exclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
1. Exclusion criteria were the same as for naive subjects, with the exception of criterion-

Study & Design

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