Status:
COMPLETED
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Infections
Eligibility:
All Genders
7-1 years
Phase:
PHASE3
Brief Summary
Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
Eligibility Criteria
Inclusion
- who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
- who have received complete primary vaccination with recommended licensed vaccines;
- who are available for all visits and telephone calls scheduled for the study;
Exclusion
- whose parent or legal guardian is unwilling or unable to give written informed assent consent
- who had a previous or suspected disease caused by N. meningitidis;
- who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
- who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
- who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination;
- 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;
- who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome
- who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine,
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- who have Down's syndrome or other known cytogenic disorders; bleeding diathesis
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1630 Patients enrolled
Trial Details
Trial ID
NCT00626327
Start Date
February 1 2008
End Date
October 1 2010
Last Update
April 19 2013
Active Locations (90)
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1
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
Birmingham, Alabama, United States, 35205
2
Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
Dothan, Alabama, United States, 36305
3
Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
Greenville, Alabama, United States, 36037
4
Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
Montgomery, Alabama, United States, 36106