Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.

Detailed Description
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The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.

Official Title
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A PHASE III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Procedure: Blood Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively. Written informed consent obtained from the parent(s)/LAR(s) of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: Child in care. History of meningococcal disease. Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036). Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACWY-TT group<br>Subjects primed and boosted with the MenACWY-TT vaccine. | Procedure: Blood Sampling<br>* At 2, 3, 4, 5, 6 years after booster vaccination.<br>|
| Active Comparator: MenCCRM group<br>Subjects primed and boosted with the Meningitec vaccine. | Procedure: Blood Sampling<br>* At 2, 3, 4, 5, 6 years after booster vaccination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 24 months after booster Vaccination | 
| Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 36 months after booster Vaccination | 
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 48 months after booster Vaccination | 
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 60 months after booster Vaccination | 
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 72 months after booster Vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Serogroups included MenA, MenC, MenW-135 and MenY. | 24, 36, 48, 60 and 72 months after booster Vaccination | 
| Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Serogroups included MenA, MenC, MenW-135 and MenY. | 24, 36, 48, 60 and 72 months after booster Vaccination | 
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to the Month 72 after booster vaccination (up to 6 years) | 
| Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Serogroups included MenA, MenC, MenW-135 and MenY. | 24, 36, 48, 60 and 72 months after booster Vaccination | 
| Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Serogroups included MenA, MenC, MenW-135 and MenY. | 24, 36, 48, 60 and 72 months after booster Vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y