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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Neisseria Meningitidis, Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: MenHibrix (Hib-MenCY-TT)
* Biological: Hib conjugate vaccine (ActHIB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenHibrix 4-dose group<br>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. | Biological: MenHibrix (Hib-MenCY-TT)<br>* First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose<br>* Other names: GSK biologicals' Hib-MenCY-TT;|
| Active Comparator: ActHIB 4-dose group<br>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. | Biological: Hib conjugate vaccine (ActHIB)<br>* First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose<br>* Other names: ActHIB;|
| Experimental: ActHIB 3-dose + MenHibrix 4th-dose group<br>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. | Biological: MenHibrix (Hib-MenCY-TT)<br>* First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose<br>* Other names: GSK biologicals' Hib-MenCY-TT;Biological: Hib conjugate vaccine (ActHIB)<br>* First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose<br>* Other names: ActHIB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humans, Meningococcal vaccines, Immunogenicity, Vaccines, H. influenzae type b vaccine, Conjugate, Toddlers, Comparative study, Neisseria meningitidis