Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year old Healthy Children who Previously Participated in Study V72P12E1

Conditions: Prevention of meningococcal disease caused by serogroup B Neisseria meningitidis by evaluating the Antibody persistence in 4-year old healthy children who previously received the Novartis meningococcal B Recombinant vaccine (rMenB+OMV NZ) as infants in study V72P12 and received a booster dose in study V72P12E1 and characterizing the antibody response to a fifth or a third booster dose or two catch-up doses of the rMenB+OMV NZ vaccine at 4 years of age.
MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-004931-30-CZ

Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1700

Inclusion Criteria

Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. Subjects eligible to be enrolled in the study should comply with the following criteria. A) Inclusion Criteria for naive subjects, newly enrolled (Group 7): 1. 4 years old (48 -60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old. 2. for whom a parent/legal guardian(s) has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian(s) confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. B) Inclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Inclusion criteria are the same as for Groups 7, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1700
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

A)Exclusion Criteria for naïve subjects, newly enrolled (Group 7):1. subjects whose parents/legal guardians are 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.history of allergic reaction to any vaccine component;
6.significant chronic infection; 7.any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive 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);8. known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants;9. participation in another clinical trial within 90 days prior to enrolment or planned for during study; 10. family members and household members of research staff. 11; any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
B. Exclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6):
Exclusion criteria are the same as for Group 7, with the exception of criterion 2 and excluding partecipation in V72P12E2 for criterion 9.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method