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Completed

NCT Number: 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

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.

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Key information

Conditions

Neisseria Meningitidis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Infections Pasteurellaceae Infections

Age range

22 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MenHibrix (Hib-MenCY-TT)

Biological

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Other names: GSK biologicals' Hib-MenCY-TT

Hib conjugate vaccine (ActHIB)

Biological

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Other names: ActHIB

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2011
First posted
Aug 3, 2006
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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