Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

Study Overview
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Brief Summary
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This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.

Official Title
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Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: Meningococcal vaccine GSK 134612
* Biological: MencevaxACWY TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol A male or female 56 years of age or older at the time of the vaccination. Written informed consent obtained from the subject. Female subjects of non-childbearing potential may be enrolled in the study. Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product. Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed. Any contra-indication to intramuscular and /or subcutaneous injection. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations). Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination. Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine. Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination. History of meningococcal disease due to serogroups A, C, W-135 or Y. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Family history of congenital or hereditary immunodeficiency. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. History of neurological disorders and seizures History of Guillain-Barre syndrome. Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. Acute disease and/or fever at the time of enrolment. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period. Pregnant or lactating female. Current chronic alcohol consumption and/or drug abuse.

Ages Eligible for Study
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Minimum Age: 56 Years

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> | Biological: Meningococcal vaccine GSK 134612<br>* Intramuscular injection<br>|
| Active Comparator: Group B<br> | Biological: MencevaxACWY TM<br>* Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) | Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination. | One month after vaccination (Month 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. | At Day 0 and Month 1 | 
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. | At Day 0 and Month 1 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | At Day 0 and Month 1 | 
| 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 ≥ 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 Day 0 and Month 1 | 
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ 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 Day 0 and Month 1 | 
| Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL). | At Day 0 and Month 1 | 
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value | The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | At Day 0 and Month 1 | 
| Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | At Day 0 and Month 1 | 
| 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 = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | Within 4 days (Day 0 to 3) post-vaccination | 
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | Within 4 days (Day 0 to 3) post-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. | Within 31 days (Day 0 to 30) after 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. | Within 31 days (Day 0 to 30) after vaccination | 
| Number of Subjects With New Onset Chronic Illnesses (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | Within 31 days (Day 0 to 30) after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neisseria meningitidis, Meningococcal Vaccines, serogroups A,C, W-135 or Y, meningococcal diseases, meningococcal conjugate vaccine, Immunogenicity