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

Conditions: heathy volunteers (Meningitis B)
MedDRA version: 15.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-004931-30-IT

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: 1560

Inclusion Criteria

A. Inclusion Criteria for naïve subjects, newly enrolled (Group 7): 1.4 years old (48 months ± 180 days window) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. 2.for whom parent/legal guardian has given written informed consent after the nature of the study has been explained; 3.for whom parent/legal guardian 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, who are 4 years old and above (preferably closer to 4 years of age).
Are the trial subjects under 18? no
Number of subjects for this age range: 1560
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 severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. significant acute or chronic infection within the previous 7 days or axillary temperature 38C within the day before Visit 1; 7. systemic use of antibiotics for treatment of significant acute or chronic infections within 7 days prior to Visit 1; 8. 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); 9.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 Visit 1; 10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11. receipt of, or intent to immunize with any other vaccine, within 30 days prior to Visit 1 (with the exception of licensed flu vaccine, which can be administered at any time during the study period, but not within 14 days of vaccination with rMenB+OMV NZ); 12. participation in another clinical trial within 90 days prior to enrolment or planned for during study; 13. family members and household members of research staff; 14. 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 participation in V72P12E1 for criterion 12.

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