A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Completed · Phase 3

Conditions studied: Meningitis, Meningococcal

In brief

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Key facts

Study ID

NCT00474526

Run by

Novartis Vaccines

People needed

4545

Starts

2007-03-01

Expected to finish

2009-11-01

Last updated by the study team

2014-03-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

You may not qualify if…

• Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Growing Up Pediatrics — Birmingham, Alabama, United States
• Premier Health Research Center, LLC — Downey, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Kaiser Permanente Med Group - Vaccine Study Ctr — Oakland, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Kaiser Permanente Pleasanton — Pleasanton, California, United States
• Kaiser Permanente Richmond — Richmond, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• UCLA Center for Vaccine Research — Torrence, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Kentucky Pediatric/Adult Research Inc. — Bardstown, Kentucky, United States
• Annapolis Pediatrics — Annapolis, Maryland, United States
• Center for Vaccine Development — Baltimore, Maryland, United States
• The Pediatric Center — Frederick, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Pediatric Associates of Fall River — Fall River, Massachusetts, United States
• Creighton University — Omaha, Nebraska, United States
• Children's Physicians Dundee — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Growing Up Pediatrics — Bessemer, Alabama, United States

Full record on ClinicalTrials.gov

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