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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00359983

Purpose

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.

Condition	Intervention	Phase
Haemophilus Influenzae Type b Infections Meningococcal Infections	Biological: GSK Biologicals' Haemophilus influenzae type b & Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 Biological: Hib conjugate vaccine	Phase II

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Ataxia Telangiectasia Flu

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	431
Study Start Date:	September 2006
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: 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.	Biological: GSK Biologicals' Haemophilus influenzae type b & Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 Primary phase: 3 intramuscular doses Booster phase: 1 intramuscular dose
Group B: Active Comparator Primary phase: Hib conjugate vaccine Booster phase: Hib conjugate vaccine Extension phase: no vaccines were administered during this long-term persistence study	Biological: Hib conjugate vaccine Primary phase: 3 intramuscular doses Booster phase: 1 intramuscular dose
Group C: 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	Biological: GSK Biologicals' Haemophilus influenzae type b & Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 Primary phase: 3 intramuscular doses Booster phase: 1 intramuscular dose Biological: Hib conjugate vaccine Primary phase: 3 intramuscular doses Booster phase: 1 intramuscular dose

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.

Eligibility

Ages Eligible for Study:	22 Months to 84 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359983

Locations

United States, Connecticut
GSK Clinical Trials Call Center
Norwich, Connecticut, United States, 06360
United States, Georgia
GSK Clinical Trials Call Center
Marietta, Georgia, United States, 30062
United States, Kentucky
GSK Clinical Trials Call Center
Bardstown, Kentucky, United States, 40004
United States, Louisiana
GSK Clinical Trials Call Center
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
GSK Clinical Trials Call Center
Boston, Massachusetts, United States, 02118
United States, New York
GSK Clinical Trials Call Center
Rochester, New York, United States, 14620
United States, Pennsylvania
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, United States, 15241

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	107824, 107826, 107829
Study First Received:	July 31, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00359983 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Comparative study
Toddlers
Humans
H. influenzae type b vaccine

Meningococcal vaccines
Neisseria meningitidis
Vaccines, conjugate
Immunogenicity

Study placed in the following topic categories:

Bacterial Infections
Ataxia-Telangiectasia
Haemophilus Influenzae
Neisseria Meningitidis
Orthomyxoviridae Infections
Meningococcal Infection
Gram-Negative Bacterial Infections
Virus Diseases

Antibodies
Respiratory Tract Infections
Respiratory Tract Diseases
Meningococcal Infections
Influenza, Human
Ataxia Telangiectasia
Immunoglobulins
Neisseriaceae Infections

Additional relevant MeSH terms:

Bacterial Infections
Virus Diseases
Communicable Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Meningococcal Infections
Influenza, Human
Orthomyxoviridae Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on July 02, 2009