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

Phase 3

Completed

• Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b
• Interventions: Biological: MenHibrix (Hib-MenCY-TT); Biological: Hib conjugate vaccine (ActHIB)

• Registration Number: NCT00359983
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-03
• Study Start: 2006-09
• Primary Completion: 2007-11
• Study Completion: 2011-05
• Results First Submitted: 2012-06-15
• Results First Submitted QC: 2012-06-15
• Results First Posted: 2012-07-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MenHibrix 4-dose group	MenHibrix (Hib-MenCY-TT)	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.
ActHIB 4-dose group	Hib conjugate vaccine (ActHIB)	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.
ActHIB 3-dose + MenHibrix 4th-dose group	Hib conjugate vaccine (ActHIB)	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.
ActHIB 3-dose + MenHibrix 4th-dose group	MenHibrix (Hib-MenCY-TT)	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.

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States