Long-Term Antibody Persistence at 1, 3 and 5 Years After a Booster Dose of Hib-MenCY-TT Vaccine Compared to ActHIB
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemophilus Infections; Meningococcal Infections
Intervention: 92014 Intramuscular injection (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This study is evaluating antibody persistence at 1, 3 & 5 years post-booster (i. e., at 2, 4 &
6 years of age, respectively) in subjects vaccinated in a previous study.
Clinical Details
Official title: A Study to Evaluate the Long-Term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Booster Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study
Study design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Immunogenicity (pre-defined titers) of the vaccine antigens (Hib, MenC, MenY) at 1, 3 & 5 yrs after a booster dose
Secondary outcome: Evaluate long-term antibody responses to Hib, MenC and MenY after vaccination with Hib-MenCY-TT as compared to licensed Hib conjugate vaccine
Detailed description:
In this long-term follow-up study, no new subjects will be recruited. All subjects
participating in this long-term follow-up study should have already participated in a
previous study.
Eligibility
Minimum age: 22 Months.
Maximum age: 79 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female children who completed the previous booster study. The age of
the child at the 3 post-booster timelines are as follows:
- Year 1: 22 to 29 months of age.
- Year 3: 44 to 55 months of age.
- Year 5: 68 to 79 months of age.
Exclusion Criteria:
- Children should not have received more than 4 doses of Hib or meningococcal serogroup
C and Y vaccine or had a history of H. influenzae type b, meningococcal serogroup C
and Y diseases.
Locations and Contacts
GSK Clinical Trials Call Center, Norwich, Connecticut 06360, United States
GSK Clinical Trials Call Center, Marietta, Georgia 30062, United States
GSK Clinical Trials Call Center, Bardstown, Kentucky 40004, United States
GSK Clinical Trials Call Center, Boosier City, Louisiana 71111, United States
GSK Clinical Trials Call Center, Boston, Massachusetts 02118, United States
GSK Clinical Trials Call Center, Rochester, New York 14620, United States
GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15241, United States
Additional Information
Starting date: September 2006
Last updated: May 9, 2008
|
