Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

Completed · Phase 3

Conditions studied: Meningococcal Infections

In brief

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.

Key facts

Study ID

NCT00616421

Run by

Novartis Vaccines

People needed

2907

Starts

2008-03-01

Expected to finish

2009-10-01

Last updated by the study team

2016-02-15

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Pediatric Research Group — Little Rock, Arkansas, United States
• Premier Health Research Center — Downey, California, United States
• Kaiser Permanente - Fremont — Fremont, California, United States
• Kaiser Permanente - Fresno — Fresno, California, United States
• Kaiser Permanente - Hayward — Hayward, California, United States
• Kaiser Permanente - Oakland — Oakland, California, United States
• Kaiser Permanente - Pleasanton — Pleasanton, California, United States
• Kaiser Permanente - San Francisco — San Francisco, California, United States
• Kaiser Permanente - San Jose — San Jose, California, United States
• Kaiser Permanente - Aurora — Aurora, Colorado, United States
• 1st Allergy & Clinical Research — Centennial, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• 1st Allergy & Clinical Research — Thornton, Colorado, United States
• Kaiser Permanente - Westminister — Westminister, Colorado, United States
• Kentucky Pediatric Research Center — Bardstown, Kentucky, United States
• Physicians to Children & Adolescents — Springfield, Kentucky, United States
• Benchmark Research — Metairie, Louisiana, United States
• St. Louis University School of Medicine — St Louis, Missouri, United States
• Meridian Clinical Research LLC — Omaha, Nebraska, United States
• Legacy Pediatrics — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Durham Pediatrics — Durham, North Carolina, United States
• Regional Pediatric Associates PA — Durham, North Carolina, United States
• Odyssey Research — Fargo, North Dakota, United States
• Children's Investigational Reserach Program — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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