A Phase IV, Multi-Center, Controlled, Open-label Study to Evaluate the Safety,Tolerability and Immunogenicity of Chiron Meningococcal C Conjugate VaccineMenjugate® when Given as First, Third or Fourth Immunization to Children 32 to 40Months of Age - N/A
- Conditions
- Healthy subjects without known medical conditions will be vaccinated against N. meningitidis serogroup C. Active prevention of meningococcal C disease caused by Neisseria meningitidis
- Registration Number
- EUCTR2004-005150-31-DE
- Lead Sponsor
- Chiron Behring GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Children eligible to be enrolled in the study are those:
1. whose parents/legal guardians(s) have given written informed consent after the nature of the study has been explained
2. a. (Group E1 + E2) healthy children, who have either previously participated and completed study M14P1 and from whom at least serum samples from visit 5 and visit 6 or 7 could be evaluated, OR
2. b. (Group E3) healthy children aged 32 to 40 months who have never received any kind of meningococcal C vaccine before
3. available for the visits schedules in the study
4. in good health as determined by
- medical history
- clinical judgment of the investigator
- pre-vaccination physical check
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
Children who are not eligible for the study are those:
1. Whose parent(s) / legal guardian(s) have not given or are unwilling to give written
informed consent to their child’s participation in the study
2. With known hypersensitivity to Menjugate, any of its components or any vaccines
contained within the routine immunization schedule
3. With unacceptable concurrent illnesses or conditions – i.e., children:
- with severe acute or chronic illness;
- who have any present or suspected serious disease such as metabolic, cardiac or
autoimmune disease or insulin dependent diabetes or any other serious disease
(e.g., with signs of cardiac or renal failure or severe malnutrition), including
progressive neurological disease
- with a genetic anomaly, e.g. Down’s syndrome
- with any immunodeficiency, including those requiring use of systemic
corticosteroids
- who have leukemia, lymphomas or neoplasm
- who have experienced significant acute or chronic infections requiring systemic
antibiotic treatment or antiviral therapy within the past 14 days
- who have experienced fever (defined as rectal temperature = 38.5°C) within the 3
days prior to study vaccination or are suffering from a present acute infectious
disease
- who have a known bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time
- who have a history of seizure disorder
- who have previously ascertained or suspected disease caused by N. meningitidis
- with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
4. With prohibited prior or concomitant medications:
- receipt of blood, blood products or a parenteral immunoglobulin preparation
- previous immunization with any non-study vaccines or investigational agents within 30 days prior to enrolment and throughout the study
- receipt of immunoglobulin
5. Who have household contact with or intimate exposure to an individual with a
positive culture of N. meningitidis serogroup C within the previous 60 days
6. Who previously received a meningococcal C vaccine of any kind (group E3 only)
7. Whose families are planning to leave the area of the study site permanently before the end of the study period
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