A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
- Conditions
- The Novartis Meningococcal A, C, W-135 and Y Vaccine is intended for prevention of meningitidis and/or septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
- Registration Number
- EUCTR2006-003476-35-GB
- Lead Sponsor
- ovartis Vaccines and Diagnostics S.r.l
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 216
1.healthy infants aged 2 months (56 – 83 days old, inclusive)
2.available for the visits scheduled in the study;
3.mother available for blood draw at Visit 1;
4.in good health as determined by:
-medical history
-clinical judgment of the investigator
-pre-vaccination check performed by a physician;
5.whose parents can give written informed consent for the infant to be enrolled in the study. The infant’s parents must be willing for the infant to receive the full primary immunization course
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
1. Whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study
2. With known hypersensitivity to any vaccines contained within the routine immunization schedule
3. With unacceptable concurrent illnesses or conditions – e.g.:
a. a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
b. a genetic anomaly, e.g. Down’s syndrome;
c. any immunodeficiency, including use of systemic corticosteroids;
d. born at less than 36 weeks gestation;
e. weighing less than 2.5 kg at birth;
f. previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
g.known bleeding diathesis, or any condition associated with a prolonged bleeding time;
4. Who have received any prohibited prior or concomitant medications - e.g.:
a. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B;
b. immunoglobulin;
c. any blood products;
5. Participating in any other clinical trial either currently or in the previous month;
6. Unable to adhere to the protocol, including plans to move from the area;
7. Other:
With any 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