The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated. All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
311
1 dose administered intramuscularly in the non-dominant deltoid region.
Research Institute for Tropical Medicine
Muntinlupa City, National Capital Region, Philippines
Philippine General Hospital
Manila, Philippines
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Time frame: After 6 years of primary vaccination
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 7 years of primary vaccination
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 8 years of primary vaccination
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 9 years of primary vaccination
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 10 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Time frame: After 6 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 7 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 8 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 9 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 10 years of primary vaccination
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 1 month after booster vaccination
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: 1 month after booster vaccination
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers \>= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer \>= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants.
Time frame: 1 month after booster vaccination
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination
Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized.
Time frame: 1 month after booster vaccination
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination
TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized.
Time frame: 1 month after booster vaccination
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Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Solicited local events:1)pain(Grade \[G\] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre\[mm\] as 0 to less than or equal to\[\<=\]20 mm, greater than\[\>\]20 to \<=50 mm,\>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than\[\<\] 37.5 degree Celsius\[°C\], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =\>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event.
Time frame: Up to 4 days post booster vaccination
Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant 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.
Time frame: Up to 31 days post booster vaccination
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
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.
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies.
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Guillain-Barre syndrome (GBS) is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently.
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis (also termed meningococcus). It causes two life threatening diseases: meningococcal meningitis and fulminant meningococcemia which often occur together. Meningococcal meningitis is defined as an inflammatory response to bacterial infection of leptomeninges (pia-arachnoid) and the sub-arachnoid space. Meningococcal meningococcemia is meningococcal septicemia when the bacteria circulate and multiply in blood and involve multiple organs. It can cause multi-organ failure and severe disability or death.
Time frame: Up to 6 months post booster vaccination