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

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

Purpose

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.

Condition	Intervention	Phase
Meningococcal Infection Haemophilus Influenzae Type b Infections	Biological: GSK Biologicals' Haemophilus influenzae type b & Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 (Hib-MenCY-TT) Biological: Hib conjugate vaccine (ActHIB)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Flu Meningococcal Infections

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-PRP Geometric Mean Concentrations (GMCs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Number of subjects with anti-PRP antibody concentrations greater than or equal to 1.0 microgram per milliliter [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
hSBA-MenC Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Number of subjects with hSBA-MenC titers greater than or equal to 1:4 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
hSBA-MenY Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Number of subjects with hSBA-MenY titers greater than or equal to 1:4 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]

Enrollment:	270
Study Start Date:	September 2006
Study Completion Date:	May 2011
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Hib-MenCY 4-dose group Subjects previously received in the primary study (NCT00129129) 3 doses of Hib-MenCY-TT vaccine co-administered with Pediarix and Prevnar and a 4th dose of Hib-MenCY-TT co-administered with Prevnar. 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 (Hib-MenCY-TT) First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose Other Name: GSK biologicals' Hib-MenCY-TT
Active Comparator: ActHIB 4-dose group Subjects previously received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.	Biological: Hib conjugate vaccine (ActHIB) First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose Other Name: ActHIB
Experimental: ActHIB 3-dose + Hib-MenCY 4th-dose group Subjects previously received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of Hib-MenCY-TT vaccine co-administered with Prevnar. 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 (Hib-MenCY-TT) First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose Other Name: GSK biologicals' Hib-MenCY-TT Biological: Hib conjugate vaccine (ActHIB) First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose Other Name: ActHIB

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.

Eligibility

Ages Eligible for Study:	22 Months to 60 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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

Locations

United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
United States, Connecticut
GSK Investigational Site
Norwich, Connecticut, United States, 06360
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30062
GSK Investigational Site
Woodstock, Georgia, United States, 30189
United States, Iowa
GSK Investigational Site
Waukee, Iowa, United States, 50263
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Louisville, Kentucky, United States, 40272
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02118
GSK Investigational Site
Fall River, Massachusetts, United States, 02724
United States, New York
GSK Investigational Site
Pittsford, New York, United States, 14534
GSK Investigational Site
Rochester, New York, United States, 14620
United States, Ohio
GSK Investigational Site
Boardman, Ohio, United States, 44512
GSK Investigational Site
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00359983 History of Changes
Obsolete Identifiers:	NCT00360113, NCT00360165
Other Study ID Numbers:	107824, 107826, 107829
Study First Received:	July 31, 2006
Last Updated:	September 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Humans
Meningococcal vaccines
Immunogenicity
Vaccines
H. influenzae type b vaccine

Conjugate
Toddlers
Comparative study
Neisseria meningitidis

Additional relevant MeSH terms:

Influenza, Human
Meningococcal Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases

Respiratory Tract Infections
Respiratory Tract Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012