Clinical Trial Results:
A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with that of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2014-003514-91 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
21 Mar 2007
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Results information
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Results version number |
v2(current) |
This version publication date |
10 Jun 2016
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First version publication date |
20 Nov 2014
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Other versions |
v1 (removed from public view) |
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
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Trial identification
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Sponsor protocol code |
V59P10
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00329849 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Sample data: Sample data | ||
Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics s.r.l
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Sponsor organisation address |
Via Fiorentina, 1, Siena, Italy, 53100
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Public contact |
Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000032-PIP01-07 | ||
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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Nov 2007
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Mar 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Mar 2007
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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 |
To compare the percentage of subjects presenting at least one severe (solicited) systemic reaction to the Novartis MenACWY conjugate vaccine with the percentage presenting at least one severe systemic reaction to the licensed meningococcal ACWY polysaccharide (PS) vaccine (Menomune) during the first 7 days (day 1 to 7) following a single injection administered to healthy children 2 to 10 years of age
To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine with the immunogenicity of a single injection of PS vaccine (Menomune), defined as the percentage of subjects with seroresponse in human serum bactericidal assay against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
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Protection of trial subjects |
Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine was not injected into a blood vessel.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 May 2006
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
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 |
Argentina: 1500
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Worldwide total number of subjects |
1500
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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) |
1500
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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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 |
Subjects were enrolled at 3 study centers in Argentina. | |||||||||||||||
Pre-assignment
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Screening details |
All enrolled subjects were included in the trial. | |||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Men ACWY-PS | |||||||||||||||
Arm description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Menomune (MenACWY PS 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 |
Subcutaneous use
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Dosage and administration details |
One 0.5 mL injection of PS vaccine was administered by SC injection
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Arm title
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Men ACWY- CRM | |||||||||||||||
Arm description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Novartis MenACWY conjugate 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 |
One 0.5 mL injection of the MenACWY conjugate vaccine was administered by IM injection
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Baseline characteristics reporting groups
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Reporting group title |
Men ACWY-PS
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Men ACWY- CRM
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Men ACWY-PS
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal PS vaccine | ||
Reporting group title |
Men ACWY- CRM
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine | ||
Subject analysis set title |
Per Protocol-primary -Men ACWY-CRM
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the MITT (Modified Intention to treat) population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.
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Subject analysis set title |
Per Protocol-primary -Men ACWY-PS
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.
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Subject analysis set title |
Per Protocol-Persistence-Men ACWY-CRM
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.
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Subject analysis set title |
Per Protocol-persistence-Men ACWY-PS
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the MITT population who received the dose of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as defined prior to unbinding.
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Subject analysis set title |
Safety-MenACWY-CRM_2 to 5 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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Subject analysis set title |
Safety-MenACWY-PS_2 to 5 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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Subject analysis set title |
Safety-MenACWY-CRM_6 to 10 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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Subject analysis set title |
Safety-MenACWY-PS_6 to 10 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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Subject analysis set title |
Safety-MenACWY-CRM_2 to 10 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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Subject analysis set title |
Safety-MenACWY-PS_2 to 10 Years
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have received a study vaccine and have post-baseline safety data.
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End point title |
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | ||||||||||||||||||||||||
End point description |
Immunogenicity was measured as the percentage of subjects with hSBA Seroresponse, directed against each of meningococcal Serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29) with MenACWY-CRM or MenACWY-PS vaccine.
Seroresponse was defined as: for subjects with a prevaccination hSBA titer <1:4, a post vaccination hSBA titer ≥1:8;
For subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of atleast four times the prevaccination titer.
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End point type |
Primary
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End point timeframe |
1 month after vaccination (day 29)
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||||||||
Statistical analysis description |
Comparison of hSBA Seroresponse for the Serogroups A one month after vaccination of MenACWYCRM and MenACWY-PS
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Comparison groups |
Men ACWY-PS v Men ACWY- CRM
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Number of subjects included in analysis |
296
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||||||
Parameter type |
Group Difference | ||||||||||||||||||||||||
Point estimate |
38
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
29 | ||||||||||||||||||||||||
upper limit |
47 | ||||||||||||||||||||||||
Variability estimate |
Standard deviation
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Notes [1] - The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%. |
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Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||||||||||
Statistical analysis description |
Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS
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Comparison groups |
Men ACWY- CRM v Men ACWY-PS
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Number of subjects included in analysis |
296
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | ||||||||||||||||||||||||
Method |
Chi-squared corrected | ||||||||||||||||||||||||
Parameter type |
Group Difference | ||||||||||||||||||||||||
Point estimate |
30
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
19 | ||||||||||||||||||||||||
upper limit |
40 | ||||||||||||||||||||||||
Notes [2] - The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%. |
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Statistical analysis title |
Statistical Analysis 3 | ||||||||||||||||||||||||
Statistical analysis description |
Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWYCRM and MenACWY-PS
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Comparison groups |
Men ACWY- CRM v Men ACWY-PS
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Number of subjects included in analysis |
296
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [3] | ||||||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||||||
Parameter type |
Group Difference | ||||||||||||||||||||||||
Point estimate |
28
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
17 | ||||||||||||||||||||||||
upper limit |
39 | ||||||||||||||||||||||||
Notes [3] - The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month post vaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%. |
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Statistical analysis title |
Statistical Analysis 4 | ||||||||||||||||||||||||
Statistical analysis description |
Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWYCRM and MenACWY-PS
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Comparison groups |
Men ACWY- CRM v Men ACWY-PS
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Number of subjects included in analysis |
296
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [4] | ||||||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||||||
Parameter type |
Group Difference | ||||||||||||||||||||||||
Point estimate |
18
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
8 | ||||||||||||||||||||||||
upper limit |
28 | ||||||||||||||||||||||||
Notes [4] - The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%. |
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End point title |
Percentages of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Post vaccination | ||||||||||||
End point description |
Safety was assessed in terms of the percentage of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
* Value for MenACWY-PS is >1 as it is not possible to add the symbols
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End point type |
Primary
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End point timeframe |
Day 1 to 7 post vaccination
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Comparison groups |
Men ACWY- CRM v Men ACWY-PS
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Number of subjects included in analysis |
1500
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [5] | ||||||||||||
Method |
[Risk ratio(MenACWY-CRM/MenACWY-PS)] | ||||||||||||
Parameter type |
Risk ratio (RR) | ||||||||||||
Point estimate |
6.37
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.82 | ||||||||||||
upper limit |
49.2 | ||||||||||||
Notes [5] - Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3. |
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End point title |
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
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End point type |
Secondary
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End point timeframe |
Day 1 and 29
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No statistical analyses for this end point |
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End point title |
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month after Vaccination With MenACWY-CRM or MenACWY-PS | ||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
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End point type |
Secondary
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End point timeframe |
Day 1 and 29
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
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End point type |
Secondary
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End point timeframe |
Day 181
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No statistical analyses for this end point |
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End point title |
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWYPS | ||||||||||||||||||||||||||||||||||||
End point description |
The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
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End point type |
Secondary
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End point timeframe |
Day 181
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No statistical analyses for this end point |
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End point title |
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
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End point type |
Secondary
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End point timeframe |
Day 1 to 7 post vaccination
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No statistical analyses for this end point |
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End point title |
Overview of SAEs | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Throughout the study
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Solicited adverse events (AEs) were collected from Day 1 through 7,serious AEs were collected from day 1 to day 181 after vaccination.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
7.1
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Reporting groups
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Reporting group title |
MenACWY-PS
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWYCRM
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Reporting group description |
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Mar 2007 |
To modify study endpoints and expand analyses to address regulatory concerns |
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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. | |||
NA | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/19895922 |