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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Neisseria Meningitidis
- Sponsor
- GlaxoSmithKline
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 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.
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 be administered during the persistence phase of the study. This Protocol Posting has been updated following Protocol amendment 3, September 2009.
Investigators
Eligibility Criteria
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:
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Time Frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Time Frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Time Frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Secondary Outcomes
- hSBA-MenY Geometric Mean Titers (GMTs)(One year, three years, and five years after the fourth dose vaccination.)
- Anti-PRP Geometric Mean Concentrations (GMCs)(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter(One year, three years, and five years after the fourth dose vaccination.)
- hSBA-MenC Geometric Mean Titers (GMTs)(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4(One year, three years, and five years after the fourth dose vaccination.)