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

Meningococcal Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359983
• Other study ID #: 107824
• Secondary ID: 107826107829
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2006
• Last updated: September 6, 2012
• Start date: September 2006
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00360113
• NCT00360165

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 2011
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Months to 60 Months

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b Infections
• Infection
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• MenHibrix (Hib-MenCY-TT)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
• Hib conjugate vaccine (ActHIB)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Locations

Country	Name	City	State
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Boardman	Ohio
United States	GSK Investigational Site	Bossier City	Louisiana
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Greenville	Pennsylvania
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsford	New York
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Waukee	Iowa
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No