To Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with One Dose of Licensed Meningococcal ACWY Conjugate administered to Healthy Children 2-10 Years of Age.
- Conditions
- Prophylaxis for Neisseria meningitidis serogroup A, C, W, and YTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-005161-72-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines & Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 2820
1. who are 2-10 years of age inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent and who have given written assent, if applicable;
2. who are available for all visits and telephone calls scheduled for the study;
3. who are in good health as determined by:
medical history
physical assessment
clinical judgment of the investigator
4. who are up-to-date with age-appropriate routine childhood vaccinations
Are the trial subjects under 18? yes
Number of subjects for this age range: 2820
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
1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study or who are unwilling or unable to give written informed assent to participate in the study;
2. whose parent or legal guardian is perceived to be unreliable or unavailable for the duration of the study period;
3. who had a previous or suspected disease caused by N. meningitidis;
4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
5. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational) (Exception: Receipt of OMP-containing Hib vaccines is permitted);
6. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
7. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within 30 days after vaccination (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
8. who have received a live viral vaccine within 30 days prior to enrollment;
9. 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;
Reason for delaying blood draw:
Antibiotics in the blood may interfere with the evaluation of antibodies (i.e., by Serum Bactericidal Activity), therefore a blood draw should be postponed if the subject has received oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw.
10. who have any serious acute, chronic or progressive disease such as
history of cancer (excluding minor non-melanoma skin cancer)
diabetes mellitus
arteriosclerotic disease
autoimmune disease
HIV infection or AIDS
blood dyscrasias
congestive heart failure
renal failure
severe malnutrition
11. who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome; Note: one febrile seizure is not a reason for exclusion
12. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component including latex;
13. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): receipt of immunosuppressive therapy within 30 days prior to enrollment (any
systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy) receipt of immunostimulants
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
14. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
15. who have Down’s syndrome or other known cytogenic disorders;
16. whose families are planning to leave the area of the study site before the end of the study perio
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