Long-Term Antibody Persistence at 1, 3 and 5 Years After a Booster Dose of GSKBiologicals Hib-MenCY-TT Vaccine Compared to ActHIB - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2006

Last Updated Date

September 2, 2008

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Anti-PRP antibody concentrations [ Time Frame: One year, three years, and five years after booster vaccination ]
hSBA-MenC antibody titers [ Time Frame: One year, three years, and five years after booster vaccination ]
hSBA- MenY antibody titers [ Time Frame: One year, three years, and five years after booster vaccination ]

Original Primary Outcome Measures ^ICMJE

Evaluate Hib concentrations > or = 0.15 mcg/ml and MenC and MenY titers > or = 1:4 at 1 year after a booster dose

Change History

Complete list of historical versions of study NCT00359983 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Anti-PRP GMCs and antibody concentrations [ Time Frame: One year, three years, and five years after booster vaccination ]
hSBA-MenC and hSBA-MenY GMTs and antibody titers [ Time Frame: One year, three years, and five years after booster vaccination ]

Original Secondary Outcome Measures ^ICMJE

Evaluate long-term antibody responses to Hib, MenC and MenY after vaccination with Hib-MenCY-TT as compared to licensed Hib conjugate vaccine

Descriptive Information

Brief Title ^ICMJE

Long-Term Antibody Persistence at 1, 3 and 5 Years After a Booster Dose of GSKBiologicals Hib-MenCY-TT Vaccine Compared to ActHIB

Official Title ^ICMJE

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

Brief 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.

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the primary and booster phases 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Haemophilus Influenzae Type b Infections
Meningococcal Infections

Intervention ^ICMJE

Biological: GSK Biologicals' Haemophilus influenzae type b & Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
Biological: Hib conjugate vaccine

Study Arms / Comparison Groups

Experimental:
Primary phase: Hib & meningococcal vaccine (GSK Biologicals' 792014 vaccine) Booster phase: Hib & meningococcal vaccine (GSK Biologicals' 792014 vaccine)

Extension phase: no vaccines were administered during this long-term persistence study.
Active Comparator: Primary phase: Hib conjugate vaccine Booster phase: Hib conjugate vaccine Extension phase: no vaccines were administered during this long-term persistence study
Experimental:
Primary phase: Hib conjugate vaccine Booster phase: Hib & meningococcal vaccine (GSK Biologicals' 792014 vaccine)

Extension phase: no vaccines were administered during this long-term persistence study

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

431

Completion Date

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male and female children who completed the previous booster study (NCT00129129). The age of the child at the 3 post-booster timelines are as follows:
- Year 1: 22 to 36 months of age.
---Year 3: 44 to 60 months of age.
---Year 5: 68 to 84 months of age.
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 booster vaccination study Hib-MenCY-TT-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

Gender

Both

Ages

22 Months to 84 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00359983

Responsible Party

Isabelle Harpigny, GSK Biologicals

Study ID Numbers ^ICMJE

107824, 107826, 107829

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP