Clinical Trial Results:
The Long-Term Antibody Persistence Of MenACWY-TT Vaccine (PF-06866681) Versus Mencevax® ACWY In Healthy Adolescents And Adults And Booster Response To MenACWY-TT Vaccine Administered At 10 Years Postprimary Vaccination.
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Summary
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EudraCT number |
2012-005639-10 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
10 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Aug 2019
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First version publication date |
01 Aug 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MENACWY-TT-099
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01934140 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Alias Study Number: C0921002 | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Aug 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Aug 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Long-term persistence phase: Six, seven, eight, nine and ten years after primary vaccination with MenACWY-TT or Mencevax ACWY, in Study 107386 [NCT00356369]. To evaluate the long-term persistence of the serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to Mencevax ACWY when administered to individuals 11-55 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titers, greater than or equal to (>=)1:8, >=1:128 and geometric mean titres (GMTs) as measured by a serum bactericidal assay using rabbit complement (rSBA).
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Apr 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Philippines: 311
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Worldwide total number of subjects |
311
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
311
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Enrollment for this study (MENACWY-TT-99) started at Year 6 post primary vaccination in study 107386 [NCT00356369]. However, as approval was not obtained from authorities until after end of Year 6, hence no planned activities was done for Year 6. | |||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
In this study, subjects from the study 107386 [NCT00356369] were followed up for assessment of persistence of immune response. And those who consented received booster vaccination and were followed up for another 6 months. | |||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Persistence Phase (Year 6-10)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ACWY-TT group | |||||||||||||||||||||||||||
Arm description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenACWY-TT Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369].
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Arm title
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MenPS group | |||||||||||||||||||||||||||
Arm description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenPS Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369].
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Period 2
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Period 2 title |
Booster Phase (6 Months)
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Is this the baseline period? |
No | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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ACWY-TT group | |||||||||||||||||||||||||||
Arm description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenACWY-TT Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369].
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Arm title
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MenPS group | |||||||||||||||||||||||||||
Arm description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenPS Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369].
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Baseline characteristics reporting groups
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Reporting group title |
ACWY-TT group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenPS group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ACWY-TT group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | ||
Reporting group title |
MenPS group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | ||
Reporting group title |
ACWY-TT group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | ||
Reporting group title |
MenPS group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | ||
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End point title |
Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titres Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination [1] | ||||||||||||
End point description |
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). Data was not collected and analyzed for this endpoint because approval was not obtained from the authorities for Year 6 activities.
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End point type |
Primary
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End point timeframe |
After 6 years of primary vaccination
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| Notes [2] - Data was not collected and analysed, Hence no activity was done for Year 6. [3] - Data was not collected and analysed, Hence no activity was done for Year 6. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Persistence Phase: Percentage of Subjects With rSBA Titres >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination [4] | ||||||||||||||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “Overall Number of Subjects Analysed” (N) signifies number of subjects evaluable for this measure.
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End point type |
Primary
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End point timeframe |
After 7 years of primary vaccination
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Persistence Phase: Percentage of Subjects With rSBA Titres >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination [5] | ||||||||||||||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here,“Number analyzed”(n): subjects analyzed for specified serogroup and “N” signifies number of subjects evaluable for this measure.
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End point type |
Primary
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End point timeframe |
After 8 years of primary vaccination
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Persistence Phase:Percentage of Subjects With rSBA Titres >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination [6] | ||||||||||||||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure.
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End point type |
Primary
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End point timeframe |
After 9 years of primary vaccination
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Persistence Phase:Percentage of Subjects With rSBA Titres >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination [7] | ||||||||||||||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure and “n”: subjects analyzed for specified serogroup.
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End point type |
Primary
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End point timeframe |
After 10 years of primary vaccination
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Persistence Phase:Geometric Mean Titres With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination [8] | ||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units. Data was not collected and analyzed for this endpoint because approval was not obtained from the authorities for Year 6 activities.
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End point type |
Primary
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End point timeframe |
After 6 years of primary vaccination
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
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| Notes [9] - Data was not collected and analysed, Hence no activity was done for Year 6. [10] - Data was not collected and analysed, Hence no activity was done for Year 6. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Persistence Phase: Geometric Mean Titres With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination [11] | ||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure.
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End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
After 7 years of primary vaccination
|
||||||||||||||||||||||||
| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Persistence Phase: Geometric Mean Titres With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination [12] | ||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure and “n”= subjects analyzed for specified serogroup.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
After 8 years of primary vaccination
|
||||||||||||||||||||||||
| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Persistence Phase: Geometric Mean Titres With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination [13] | ||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
After 9 years of primary vaccination
|
||||||||||||||||||||||||
| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Persistence Phase:Geometric Mean Titres With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination [14] | ||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. All eligible subjects who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of subjects evaluable for this measure and “ n”: subjects analyzed for specified serogroup.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
After 10 years of primary vaccination
|
||||||||||||||||||||||||
| Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analysed for this endpoint. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
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End point title |
Booster Phase: Percentage of Subjects With rSBA Titres >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | ||||||||||||||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of subjects evaluable for this measure.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1 month after booster vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Booster Phase: Geometric Mean Titres With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | ||||||||||||||||||||||||
End point description |
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titres expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. All eligible subjects who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of subjects evaluable for this measure.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 month after booster vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Booster Phase: Percentage of Subjects With rSBA Booster Response at 1 Month After Booster Vaccination | ||||||||||||||||||||||||
End point description |
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 subjects (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers >= 1:32, 1 month after vaccination, and for initially seropositive subjects (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 subjects. All eligible subjects: received primary vaccination in study 107386[NCT00356369] and booster dose in study MENACWY-099;assay results available for antibodies against at least 1 study vaccine antigen component in blood sample taken 1 month post vaccination. N= subjects evaluable for measure, n= subjects analyzed for specified serogroups.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 month after booster vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Booster Phase: Percentage of Subjects 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 | ||||||||||||||||||
End point description |
Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of subjects with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized. All eligible subjects who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N= subjects evaluable for this measure.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
1 month after booster vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against–Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination | ||||||||||||
End point description |
TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of subjects with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized. All eligible subjects who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N= subjects evaluable for this measure.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
1 month after booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Booster Phase: Percentage of Subjects With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local events:1)pain(Grade[G]:0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, interfered normal activities,3=severe, prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre[mm] as 0 to <=20 mm, >20 to <=50 mm,>50 mm). 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: Fever (G: 1= >=37.5 degree Celsius [°C] - <=38.0 degree C, 2= >38.0 degree C - <=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. All eligible subjects who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099. n: subjects analyzed for specified categories.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
up to 4 days post booster vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Percentage of Subjects With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination | ||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject, 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 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. All eligible subjects who received primary vaccination in study 107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
up to 31 days post booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Percentage of Subjects With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | ||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject 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. All eligible subjects who received primary vaccination in study 107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 6 months post booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Percentage of Subjects With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | ||||||||||||
End point description |
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies. All eligible subjects who received primary vaccination in study 107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 6 months post booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Percentage of Subjects With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | ||||||||||||
End point description |
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. All eligible subjects who received primary vaccination in study 107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 6 months post booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Booster Phase: Percentage of Subjects With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | ||||||||||||
End point description |
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. All eligible subjects who received primary vaccination in study 107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 6 months post booster vaccination
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
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Timeframe for reporting adverse events |
For persistence phase: Through 4 years (7, 8, 9 and 10 years post primary vaccination) Non-SAEs not collected for persistence phase; Booster phase: upto 6 months after booster vaccination;Local and General events: upto 4 days post booster vaccination.
|
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Adverse event reporting additional description |
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 subject and non-serious in other, or subject may experienced both SAE and non-SAE. Persistence Phase: all subjects enrolled in MENACWY-099. Booster Phase: all eligible subject who received primary vaccination in 107386[NCT00356369], booster vaccine in MENACWY-099.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.0
|
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Reporting groups
|
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Reporting group title |
Booster Phase: ACWY-TT group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Booster Phase: MenPS group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Persistence phase: ACWY-TT group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 [NCT00356369], and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Persistence phase: MenPS group
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Reporting group description |
Persistence phase was followed up by booster phase. Persistence phase: Subjects received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 [NCT00356369]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible subjects from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Enrollment for this study (MENACWY-TT-99) started at Year 6. However, Study visit for Year 6 was not done because approval was not obtained from the authorities until after the end of the Year 6. Hence, no planned activities were done for Year 6. | |||
