A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study toEvaluate the Safety and Immunogenicity of Chiron Meningococcal ACWY ConjugateVaccine in Healthy Children Aged 12-59 Months

• Conditions: Prevention of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y

• Registration Number: EUCTR2004-001896-21-FI
• Lead Sponsor: Chiron S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. healthy 12-<60 month old children;
2. for whom a parent/legal guardian has given written informed consent after the
nature of the study has been explained;
3. available for all the visits scheduled in the study;
4. in good health as determined by:
• medical history
• physical examination
• clinical judgment of the investigator.
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

Exclusion Criteria

Children who should not be enrolled in the study are those:
1.whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study;
2.who have previously received any meningococcal vaccine;
3.who have a previous ascertained or suspected disease caused by N. meningitidis;
4.who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection;
5.who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
6.who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature =38.0°C or rectal temperature =38.5°C) within 3 days previous to immunization;
7.who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome)
8.who have received another vaccine within the past 30 days from first or second immunization or any blood draw
9.who have received any investigational agent (including vaccine) within the past 90 days from first or second immunization or any blood draw
10.who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
a)administration of any immunosuppressive therapy
b)administration of any immunostimulants
c)administration of any sytemic corticosteroid administered for more than 4 days in the previous 30 days
11.with a suspected or known HIV infection or HIV related disease;
12.who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
13.with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding;
14.who have a history of any seizure disorder;
15.who have taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who have received an oral or parenteral ß-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose of antibiotic);
16.who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period;
17.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