Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

Completed · Phase 3

Conditions studied: Meningococcal Disease, Infections, Meningococcal

In brief

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Key facts

Study ID

NCT01682876

Run by

GlaxoSmithKline

People needed

715

Starts

2012-10-07

Expected to finish

2014-05-30

Last updated by the study team

2019-06-14

Who can join

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

You may qualify if…

• Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

You may not qualify if…

• Unwilling or unable to give written informed assent or consent to participate in the study.
• Perceived to be unreliable or unavailable for the duration of the study period.
• Previous confirmed or suspected disease caused by N. meningitidis.
• Previously immunized with a meningococcal vaccine (licensed or investigational).
• Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
• Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
• (certain exceptions influenza vaccines apply)
• Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
• Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
• History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
• Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy,
• receipt of immunostimulants,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
• Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Lake Mary, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Council Bluffs, Iowa, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Niles, Michigan, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — Bellevue, Nebraska, United States
• GSK Investigational Site — Fremont, Nebraska, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Johnson City, New York, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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