Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

Study Overview
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Brief Summary
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The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Detailed Description
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The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

Official Title
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Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: Meningococcal vaccine GSK134612


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment. Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site. Written informed consent obtained from parents/guardian of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine. Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination). Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y. History of meningococcal diseases. Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. History of reactions or allergic disease likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at the time of enrollment. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 9 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Single dose GSK134612. | Biological: Meningococcal vaccine GSK134612<br>* One or 2 intramuscular injections.<br>|
| Experimental: Group B<br>Two doses of GSK134612. | Biological: Meningococcal vaccine GSK134612<br>* One or 2 intramuscular injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. | One month after the last dose (at Month 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. | One month after the first dose (at Month 1) | 
| Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | 
| hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | 
| Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | 
| Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | 
| Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL). | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | 
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL). | At Month 1 (GSK 134612 s doses Group only) and Month 4 | 
| Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | 
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | 
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | 
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Up to 1 month post-vaccination | 
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Up to study end (Month 9) | 
| Number of Subjects With New Onset Chronic Ilnesses (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | Up to study end (Month 9) | 
| Number of Subjects Reporting Rash | Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae. | Up to study end (Month 9) | 
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases. | Up to study end (Month 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neisseria meningitidis;, Humans;, Meningococcal vaccines;, Safety, Vaccines, conjugate;, Toddlers;, Immunogenicity;