The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.
The study aims to evaluate the antibody persistence post primary vaccination with active control, safety and immunogenicity of a booster dose uncontrolled post primary vaccination during different phases: Persistence phase: Long-term persistence 6, 7, 8, 9 and 10 years after primary vaccination with MenACWY-TT or Meningitec or Mencevax ACWY, in study MenACWY-TT-027. Booster phase: One month post booster vaccination with MenACWY-TT vaccine ten years after primary vaccination. The subjects in this study will be allocated to the same groups as in the vaccination study MenACWY-TT-027 (NCT00427908).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
243
One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
Espoo Vaccine Research Clinic
Espoo, Finland
South Helsinki Vaccine Research Clinic
Helsinki, Finland
Helsinki East Vaccine Research Clinic
Helsinki, Finland
Jarvenpaa Vaccine Research Clinic
Jarvenpaa, Finland
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
Oulu, Finland
Tampereen yliopisto/ Porin rokotetutkimusklinikka
Pori, Finland
Tampere Vaccine Research Clinic
Tampere, Finland
Tampereen yliopisto/ Turun rokotetutkimusklinikka
Turku, Finland
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
Vantaa, Finland
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=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: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100)
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: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
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: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
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: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
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: 10 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 10 years after primary vaccination (Year 5 of study MENACWY-TT-100)
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
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 (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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 response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer \>= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination.
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
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Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Geometric Mean Titers Using hSBA 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 (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer \>= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination.
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy
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. AEs related to "lack of vaccine efficacy" were as judged by the investigator.
Time frame: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (\>=37.5°C for oral/axillary/tympanic route, \>=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to \<=20 mm, \>20 to \<=50 mm, \>50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator.
Time frame: Up to 4 days post booster vaccination
Booster Phase: Percentage of Participants With Unsolicited Adverse Events 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) Up to 6 Months 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. 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 Up to 6 Months Post Booster Vaccination
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Up to 6 months post booster vaccination