Clinical trial NCT00359983: Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Haemophilus Influenzae Type b
Keywords: Humans
Meningococcal vaccines
Immunogenicity
Vaccines
H. influenzae type b vaccine
Conjugate
Toddlers
Comparative study
Neisseria meningitidis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 270
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: 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)
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: 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)
timeFrame: One year, three years, and five years after the fourth dose vaccination.
Secondary outcomes:
measure: Anti-PRP Geometric Mean Concentrations (GMCs)
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: hSBA-MenC Geometric Mean Titers (GMTs)
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: hSBA-MenY Geometric Mean Titers (GMTs)
timeFrame: One year, three years, and five years after the fourth dose vaccination.
measure: Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
timeFrame: One year, three years, and five years after the fourth dose vaccination.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Waukee
country: United States
facility: GSK Investigational Site
state: Iowa
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Pittsford
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Boardman
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.