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

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.

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.

Study Overview

• Status: Completed
• Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: MenHibrix (Hib-MenCY-TT); Biological: Hib conjugate vaccine (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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: GSK biologicals' Hib-MenCY-TT; Biological: Hib conjugate vaccine (ActHIB); First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose; Other Names: ActHIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
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)	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
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)	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-PRP Geometric Mean Concentrations (GMCs)	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.	One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
hSBA-MenC Geometric Mean Titers (GMTs)	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.	One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
hSBA-MenY Geometric Mean Titers (GMTs)	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.	One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
• Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
• 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.
• Marshall GS, Blatter M, Marchant C, Aris E, Mesaros N, Miller JM. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) given at 12-15 months of age. Pediatr Infect Dis J. 2013 Jun;32(6):662-8. doi: 10.1097/INF.0b013e3182840e35.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: August 2, 2006
• First Posted (Estimate): August 3, 2006

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Vaccines; Immunogenicity; Comparative study; Neisseria meningitidis; Meningococcal vaccines; Toddlers; Conjugate; H. influenzae type b vaccine
• Other Study ID Numbers: 107824; 107826 (Other Identifier: GSK); 107829 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 107824
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register