Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 2 - 10 |
Updated: | 4/21/2016 |
Start Date: | March 2008 |
End Date: | October 2009 |
A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given
to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein
conjugate vaccine.
to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein
conjugate vaccine.
Inclusion Criteria:
- healthy 2-10 years of age children, inclusive and for whom, after the nature of the
study has been explained, the parent or legal guardian has provided written informed
consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion Criteria:
- whose parent or legal guardian is unwilling or unable to give written informed
consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing
meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to
enrollment
- who have any serious acute, chronic or progressive disease
- who have epilepsy or any progressive neurological disease or history of Guillain
Barré Syndrome
- who have a history of anaphylaxis, serious vaccine reactions
- who have a known or suspected impairment/alteration of immune function, either
congenital or acquired or resulting from
- who are known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time
- who have Down's syndrome or other known cytogenic disorders
We found this trial at
50
sites
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Kaiser Permanente - Fremont You can rely on Kaiser Permanente for quality care, delivered with...
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