A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.
A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.
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.
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 be administered during the persistence phase of the study.
This Protocol Posting has been updated following Protocol amendment 3, September 2009.
Inclusion Criteria:
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:
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 Criteria:
Children should not have: