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

• 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. ] [ Designated as safety issue: No ]
  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) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
  Results up to 5 years after the fourth dose are presented.
• 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. ] [ Designated as safety issue: No ]
  Results up to 5 years after the fourth dose are presented.

• Anti-PRP Geometric Mean Concentrations (GMCs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]

  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 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
  Results up to 5 years after the fourth dose are presented.
• hSBA-MenC Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]

  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 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
  Results up to 5 years after the fourth dose are presented.
• hSBA-MenY Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]

  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-MenY Titers Greater Than or Equal to 1:4 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
  Results up to 5 years after the fourth dose are presented.

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.

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.

• Meningococcal Infection
• Haemophilus Influenzae Type b Infections

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

• 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.
  Intervention: Biological: MenHibrix (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.
  Intervention: Biological: Hib conjugate vaccine (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.
  Interventions:

  • Biological: MenHibrix (Hib-MenCY-TT)
  • Biological: Hib conjugate vaccine (ActHIB)

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