Research Institute for Tropical Medicine
Muntinlupa City, National Capital Region, 1781, Philippines
NCT Number: NCT03189745
This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY
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Notify Me20 year–28 year
All sexes
Interventional
Phase 3
Muntinlupa City, National Capital Region, 1781, Philippines
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Please refer to the GLOSSARY OF TERMS for the definitions of menarche and post-menopause.
Exclusion criteria
Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY
Time frame: 1 month after booster 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). The rSBA titer levels greater than or equal to (>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer >=1:8. Data reported below is including both seropositive and seronegative participants.
Time frame: Before booster vaccination, 1 month after booster vaccination (Vac)
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: Before booster vaccination, 1 month after booster vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Time frame: Before booster vaccination, 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: Before booster vaccination, 1 month after booster vaccination
TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. The GMCs calculations was performed by taking the anti-log of the mean of the log concentration transformations. Antibody (Anti-TT) concentrations below the cut-off value (0.1 IU/mL) of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation.
Time frame: Within 4 days post booster vaccination (Day 0 to Day 3)
Solicited local reactions included pain, redness and swelling. Pain graded as: (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 scored as:0= None, 1= 0 to less than or equal to (<=) 20 millimeter (mm), 2= greater than (>) 20 to <=50 mm, 3=>50 mm. Solicited general reactions: headache, fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea /abdominal pain) graded as (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe / prevented normal activity). Fever categorized as: 0= less than (<) 37.5 degree Celsius (C), 1= >=37.5 to <=38.5 degree C, 2= >38.5 to <=39.5 degree C, and 3= >39.5 degree C.
Time frame: 31 days after booster vaccination (Day 0 to Day 30)
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. And any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: Within 31 days after booster vaccination (Day 0 to Day 30)
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. 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. All occurrences of GBS has to be reported as an SAE. New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: 10 years after primary 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. Occurrence of SAEs related to primary vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the participant's last visit in the primary study 109069 (NCT00464815) or in persistence study 112148 (NCT00974363); extension study: 109069 (NCT00464815) at Year 2, 3, 4, 5 after primary vaccination until entry in study MenACWYTT-101, which is extension of study 109069 (NCT00464815), 10 years post primary vaccination.
Time frame: 10 years after primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 10 years after primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units.
Pfizer
Industry
A PHASE IIIB, OPEN STUDY TO EVALUATE THE IMMUNOGENICITY, REACTOGENICITY AND SAFETY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER HEALTHY SUBJECTS AGED 11-17 YEARS RECEIVED EITHER MENACWY-TT VACCINE (NIMENRIX(REGISTERED)) OR MENCEVAX ACWY(REGISTERED).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.