Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

Completed · Phase 3

Conditions studied: Meningococcal Disease, Meningococcal Meningitis

In brief

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Key facts

Study ID

NCT01214837

Run by

Novartis Vaccines

People needed

751

Starts

2010-10-01

Expected to finish

2012-05-01

Last updated by the study team

2018-10-09

Who can join

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

You may qualify if…

• Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

You may not qualify if…

• Serious, acute, or chronic illnesses are reasons for exclusion.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Madera, California, United States
• Study site — Nampa, Idaho, United States
• Cotton ONeil Clinical Research — Topeka, Kansas, United States
• Cotton ONeil Clinical Research — Topeka, Kansas, United States
• Study site — Bardstown, Kentucky, United States
• Bluegrass Clinical Research (Bardstown Road) — Louisville, Kentucky, United States
• Bluegrass Clinical Research (Brownsboro Park Blvd) — Louisville, Kentucky, United States
• Study site — Springfield, Kentucky, United States
• Study site — Haughton, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Niles, Michigan, United States
• Study site — Lincoln, Nebraska, United States
• Children's Physicians Dundee — Omaha, Nebraska, United States
• Creighton Univ — Omaha, Nebraska, United States
• Study site — Binghamton, New York, United States
• Study site — Johnson City, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Dayton, Ohio, United States
• Study site — Huber Heights, Ohio, United States

Full record on ClinicalTrials.gov

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