Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

Completed · Phase 3

Conditions studied: Neisseria Meningitidis, Haemophilus Influenzae Type b

In brief

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Key facts

Study ID

NCT00359983

Run by

GlaxoSmithKline

People needed

270

Starts

2006-09-01

Expected to finish

2011-05-01

Last updated by the study team

2016-12-16

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
• Year 1: 22 to 36 months of age.
• Year 3: 44 to 60 months of age.
• Year 5: 5 years post-dose 4 +/- 8 weeks
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study
• Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

You may not qualify if…

• Children should not have:
• received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
• had a history of H. influenzae type b, meningococcal serogroup C and Y diseases

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Waukee, Iowa, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Fall River, Massachusetts, United States
• GSK Investigational Site — Pittsford, New York, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Boardman, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Greenville, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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