Status:
COMPLETED
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neisseria Meningitidis
Haemophilus Influenzae Type b
Eligibility:
All Genders
22-60 years
Phase:
PHASE3
Brief Summary
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 dea...
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. No vaccine will...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00359983
Start Date
September 1 2006
End Date
May 1 2011
Last Update
December 16 2016
Active Locations (21)
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1
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
2
GSK Investigational Site
Fountain Valley, California, United States, 92708
3
GSK Investigational Site
Norwich, Connecticut, United States, 06360
4
GSK Investigational Site
Marietta, Georgia, United States, 30062