A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
- Conditions
- ovartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitidis and septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
- Registration Number
- EUCTR2007-004978-16-GB
- 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
- 476
Participants eligible to be enrolled in the follow-on study are those who:
1. have completed the V59P5 study;
2. are healthy children age 40 months inclusive (+84 days) (Visit 7) or 60 months (+84 days) (Visit 8);
3. are children in good health as determined by:
- medical history;
- physical assessment;
- clinical judgment of the investigator;
4. children whose parent(s) give written informed consent for their child to be enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Participants who are not eligible for the follow up study are those:
1. whose parents have not given or are unwilling or unable to give written informed consent for their child’s participation in the study;
2. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
a. receipt of immunosuppressive therapy within the past 30 days (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1mg/kg/day prednisone or equivalent during any of the previous 30 days, or cancer chemotherapy);
b. receipt of immunostimulants;
c. receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within the past 90 days and for the full length of the study;
3. who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis serogroup A, C, W, or Y infection within 60 days prior to enrollment;
4. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature = 38°C) within 3 days prior to enrollment;
5. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
6. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any study vaccine component (including latex allergy);
7. who have any serious acute, chronic or progressive disease such as
a. history of cancer (excluding minor non-melanoma skin cancer)
b. diabetes mellitus
c. arteriosclerotic disease
d. autoimmune disease
e. HIV infection or AIDS
f. blood dyscrasias
g. congestive heart failure
h. renal failure
i. severe malnutrition
8. who have a condition that is a contraindication to vaccination;
9. who are participating in any other clinical trial either currently or in the previous 90 days prior to enrolment;
10. who are unable to adhere to the protocol;
11. who have a condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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