A Phase IIIB, Open Label, Multi-Center Extension Study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28.

Phase 1

• Conditions: A phase IIIB, Open Label, Multi Center extension study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28.; MedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000657-30-ES
• Lead Sponsor: ovartis Vaccines and Diagnostics s.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

Subject eligible to be enrolled in this study are healthy subjects who previously participated to the parental trial V72_28.
Naïve subjects eligible to participate in this trial should not have a history of any meningococcal B vaccine administration.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1350
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 naïve subjects newly enrolled:
1. History of any serogroup B meningococcal vaccine administration;
2. Previous known or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;
4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;
5. Pregnancy or nursing (breastfeeding) mothers;
6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility 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;
7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
- Receipt of any chronic immunosuppressive therapy
- Receipt of any chronic immunostimulants
- Immune deficiency disorder, or known HIV infection
8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).
9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
10. Subject' s parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
11. Intent to participate in another clinical study during this study.
12. Family members and household members of study staff;
13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
14. Any significant chronic infection.
15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Exclusion Criteria for Subjects who participated in the V72_28 study (Follow-on Subjects):
Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.

Study & Design

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