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

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ClinicalTrials.gov Identifier: NCT00359983
Recruitment Status : Completed
First Posted : August 3, 2006
Results First Posted : July 20, 2012
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neisseria Meningitidis Haemophilus Influenzae Type b Biological: MenHibrix (Hib-MenCY-TT) Biological: Hib conjugate vaccine (ActHIB) Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Anti-PRP Geometric Mean Concentrations (GMCs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ]

    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.


  2. 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. ]
    Results up to 5 years after the fourth dose are presented.

  3. hSBA-MenC Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ]

    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.


  4. 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. ]
    Results up to 5 years after the fourth dose are presented.

  5. hSBA-MenY Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ]

    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.


  6. 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. ]
    Results up to 5 years after the fourth dose are presented.


Eligibility Criteria
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Ages Eligible for Study:   22 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359983


Locations
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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, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107824
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Marshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359983    
Obsolete Identifiers: NCT00360113, NCT00360165
Other Study ID Numbers: 107824
107826 ( Other Identifier: GSK )
107829 ( Other Identifier: GSK )
First Posted: August 3, 2006    Key Record Dates
Results First Posted: July 20, 2012
Last Update Posted: December 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Humans
Meningococcal vaccines
Immunogenicity
Vaccines
H. influenzae type b vaccine
 Conjugate
Toddlers
Comparative study
Neisseria meningitidis