Clinical Trial Results:
A phase II, observer-blinded, multi-center, controlled study to assess the safety and immunogenicity of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus toxoid conjugate vaccine (MenACWY-TT) versus one dose of Sanofi Pasteur’s meningococcal serogroups A, C, W-135 and Y vaccine (Menactra) in healthy subjects aged 10 through 25 years.
|
Summary
|
|
EudraCT number |
2012-001305-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Jul 2011
|
|
Results information
|
|
Results version number |
v3(current) |
This version publication date |
16 Sep 2018
|
First version publication date |
29 Jul 2015
|
Other versions |
v1 , v2 |
Version creation reason |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
114249
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01165242 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
12 Jan 2012
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
25 Feb 2011
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Jul 2011
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To demonstrate the non-inferiority of MenACWY-TT (Lot A) vaccine when compared to MenACWY-DT vaccine in terms of the percentage of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroup A (hSBA-MenA), serogroup C (hSBA-MenC), serogroup W-135 (hSBA-MenW-135) and serogroup Y (hSBA-MenY) vaccine response one month after vaccination.
|
||
Protection of trial subjects |
Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Aug 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 713
|
||
Country: Number of subjects enrolled |
Canada: 300
|
||
Worldwide total number of subjects |
1013
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
1013
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||||||||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||
Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start. | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment period milestones
|
|||||||||||||||||||||||||||||||||||||||||
Number of subjects started |
1013 | ||||||||||||||||||||||||||||||||||||||||
Number of subjects completed |
1011 | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment subject non-completion reasons
|
|||||||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
No vaccination received: 2 | ||||||||||||||||||||||||||||||||||||||||
|
Period 1
|
|||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall (overall period)
|
||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | ||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
Data were collected in an observer-blind manner during this study. The blinding was observer-blind with respect to lots of MenACWY-TT and observer-blind with respect to MenACWY-TT or Menactra. By observer-blind, it was meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were all unaware of which vaccine was administered.
|
||||||||||||||||||||||||||||||||||||||||
|
Arms
|
|||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
Nimenrix A Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nimenrix
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
Meningococcal vaccine GSK 134612
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
One intramuscular injection administered in the deltoid region of the non-dominant arm.
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
Nimenrix B Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nimenrix
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
Meningococcal vaccine GSK 134612
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
One intramuscular injection administered in the deltoid region of the non-dominant arm.
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
Menactra Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Menactra
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
MenACWY-DT vaccine
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
One intramuscular injection administered in the deltoid region of the non-dominant arm.
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start. |
|||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix A Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix B Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Menactra Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Nimenrix A Group
|
||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||
Reporting group title |
Nimenrix B Group
|
||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||
Reporting group title |
Menactra Group
|
||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||
|
||||||||||||||||||||||
End point title |
Number of subjects with vaccine response to serum bactericidal assay using human complement against Neisseria meningitidis serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibodies [1] [2] | |||||||||||||||||||||
End point description |
Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
One month after the vaccination (Month 1)
|
|||||||||||||||||||||
| 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Reporting for hSBA results was done separately for the baseline groups. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ the cut-off value | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to (PRE) and one month after vaccination (Month 1)
|
||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ the cut-off value | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to (PRE) and one month after vaccination (Month 1)
|
||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers are presented as geometric mean titers (GMTs).
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to (PRE) and one month after vaccination (Month 1)
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||
End point title |
Number of subjects with vaccine response for hSBA antibodies [3] | ||||||||||||||
End point description |
|||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
One month after vaccination
|
||||||||||||||
| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Reporting for hSBA results was done separately for the baseline groups. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with any and grade 3 solicited local symptoms | ||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 4 days (Day 0 - Day 3) following vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with any, grade 3 and related solicited general symptoms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 4 days (Day 0 - Day 3) following vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Occurrence of unsolicited non-serious Adverse Events (AEs) | ||||||||||||||||
End point description |
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Within 31 days (Day 0 to 30) following vaccination
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Number of subjects with occurrence of New Onset of Chronic Illness(es) [NOCI(s)] | ||||||||||||||||
End point description |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Month 0 through Month 6
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Number of subjects with Serious Adverse Events (SAEs) | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Month 0 through Month 6
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 6).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix A Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix B Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Menactra Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
16 Mar 2010 |
Amendment 3
The introduction was updated with the current licensing status of competitor vaccines and the current recommendations for meningococcal vaccines.
The primary objective of the current study is to demonstrate the non-inferiority of MenACWY-TT (Lot A) when compared to Menactra at 10-25 years of age in terms of the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY vaccine response* one month after vaccination.
*Vaccine response is defined as an hSBA titer of at least 1:8 in subjects initially seronegative (hSBA titer <1:4) and as a 4-fold increase in titer in subjects initially seropositive (hSBA titer 1:4).
In addition, to support the data obtained by hSBA testing, antibody concentrations against meningococcal polysaccharides were planned to be assessed by ELISA. The sponsor decided not to perform the ELISA testing for the following reasons:
• the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningoccoccal conjugate vaccines [WHO, 2006;WHO, 1999]
• circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal polysaccharides [CDC, 2011; WHO, 2006].
Section 6.2 (Storage and handling of study vaccines) has been modified in order to align the wording with the new version of SOP-BIO-CLIN-7055 v04 entitled “Management of the Cold Chain for GlaxoSmithKline Biologicals investigational human subject research” effective since 31 March 2010.
|
||
06 Sep 2010 |
• The MenA capsular polysaccharide O-acetylation in MenACWY-TT vaccine Lot A will be 68% instead of 61%.
• Mencevax™ ACWY is not licensed in Canada.
• Menveo® (Novartis’ meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) was recently licensed in Canada.
• A new abbreviation was added to the List of Abbreviations.
• For clarification, the word “days” was added after “180-210” in Table 3 Intervals between study visits.
• For clarification, the 31-day post-vaccination reporting period for pregnancies was added to Figure 1.
• New safety reporting telephone numbers replaced the old numbers.
New study contact for emergency code break telephone numbers replaced the old numbers.
|
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
