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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359983
First received: July 31, 2006
Last updated: September 6, 2012
Last verified: August 2012
  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: MenHibrix (Hib-MenCY-TT)
Biological: Hib conjugate vaccine (ActHIB)
Phase 3

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:


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 ]
    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. ] [ Designated as safety issue: No ]
    Results up to 5 years after the fourth dose are presented.

  • 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 ]
    Results up to 5 years after the fourth dose are presented.


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 ]

    Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).

    Results up to 5 years after the fourth dose are presented.


  • 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 ]
    Results up to 5 years after the fourth dose are presented.

  • 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 ]

    Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.

    Results up to 5 years after the fourth dose are presented.


  • 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 ]
    Results up to 5 years after the fourth dose are presented.

  • 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 ]

    Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.

    Results up to 5 years after the fourth dose are presented.


  • 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 ]
    Results up to 5 years after the fourth dose are presented.


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: MenHibrix 4-dose group
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
Biological: MenHibrix (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 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 + MenHibrix 4th-dose group
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
Biological: MenHibrix (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 40202
GSK Investigational Site
Louisville, Kentucky, United States, 40272
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, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Marshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359983     History of Changes
Obsolete Identifiers: NCT00360113, NCT00360165
Other Study ID Numbers: 107824, 107826, 107829
Study First Received: July 31, 2006
Results First Received: June 15, 2012
Last Updated: September 6, 2012
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 August 20, 2014