Clinical Trial Results:
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers
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Summary
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EudraCT number |
2017-001993-40 |
Trial protocol |
FI |
Global end of trial date |
10 Sep 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2020
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First version publication date |
05 Jan 2020
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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 |
MET62
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03476135 | ||
WHO universal trial number (UTN) |
U1111-1183-5988 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur Inc.
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Sponsor organisation address |
Discovery Drive, Swiftwater, PA, United States, 18370
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Public contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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-001930-PIP01-16 | ||
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 |
18 Oct 2019
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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 Sep 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 |
Immunogenicity:
1) To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW) or Nimenrix® 3 years earlier as toddlers.
2) To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
3) To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
Safety:
To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
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Protection of trial subjects |
Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Feb 2018
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Long term follow-up planned |
No
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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 |
Finland: 91
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Worldwide total number of subjects |
91
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EEA total number of subjects |
91
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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) |
91
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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 |
Study subjects were enrolled at 8 sites in Finland from 27 February 2018 to 7 August 2018. | |||||||||
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Pre-assignment
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Screening details |
A total of 91 subjects who received a single dose of MenACYW conjugate vaccine or Nimenrix® vaccine in previous study MET54 (EudraCT ID: 2014-004367-20/NCT03205358) were enrolled in this study (MET62). | |||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
MET62 was an open-label study.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) | |||||||||
Arm description |
Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 millilitre (mL), intramuscular, single dose on Day 0.
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Arm title
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Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | |||||||||
Arm description |
Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular, single dose on Day 0.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
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Reporting group description |
Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
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Reporting group description |
Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
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Reporting group description |
Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||
Reporting group title |
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
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Reporting group description |
Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||
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End point title |
Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine [1] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all subjects who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample results and had no protocol deviations.
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End point type |
Primary
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End point timeframe |
Day 0
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine [2] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on PPAS.
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End point type |
Primary
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End point timeframe |
Day 30 (post-booster vaccination)
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| Notes [2] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine [3] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using baby rabbit complement (rSBA). Analysis was performed on PPAS. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Day 0
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| Notes [3] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine [4] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. Analysis was performed on PPAS.
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End point type |
Primary
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End point timeframe |
Day 30 (post-booster 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62 [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on Full Analysis Set for Persistence (FASP) which included all subjects who had a valid pre-vaccination blood sample result. Here 'n' signifies number of subjects with available data for specified category and "-99999" & "99999" signifies no data calculated for 95% confidence interval field, because everyone’s baseline value in MET54 was 2 for the specified category.
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End point type |
Primary
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End point timeframe |
Day 0 from study MET54, Day 30 (post-priming vaccination) from study MET54, Day 0 from study MET62 and Day 30 (post booster-vaccination) from study MET62
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62 [6] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. Analysis was performed on FASP. Here 'n' signifies number of subjects with available data for specified category and "-99999" &"99999" signifies no data calculated for 95% confidence interval field, because everyone’s baseline value in MET54 was 2 for the specified category.
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End point type |
Primary
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End point timeframe |
Day 0 from study MET54, Day 30 (post-priming vaccination) from study MET54, Day 0 from study MET62 and Day 30 (post booster-vaccination) from study MET62
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine [7] | ||||||||||||
End point description |
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. Analysis was performed on PPAS. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Day 0
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine [8] | ||||||||||||
End point description |
Anti-tetanus antibodies were measured by ECL assay. Analysis was performed on PPAS.
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End point type |
Primary
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End point timeframe |
Day 30 (post-booster 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Immediate Adverse Event After Vaccination [9] | ||||||||||||
End point description |
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. Analysis was performed on safety analysis set which included subjects who had received at least one dose of the study vaccine and had any safety data available.
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End point type |
Primary
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End point timeframe |
Within 30 minutes after vaccination
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| Notes [9] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Solicited Injection Site Reactions and Systemic Reactions [10] | |||||||||||||||||||||||||||||||||
End point description |
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia. Analysis was performed on safety analysis set.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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| Notes [10] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects with Unsolicited Adverse Event After Vaccination [11] | ||||||||||||
End point description |
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
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End point type |
Primary
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End point timeframe |
Within 30 days after vaccination
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| 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects with a Serious Adverse Event (SAE) During the Study [12] | ||||||||||||
End point description |
A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. Analysis was performed on safety analysis set.
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End point type |
Primary
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End point timeframe |
Within 30 days after vaccination
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| 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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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 |
SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
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Adverse event reporting additional description |
SR was an AR observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
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Reporting group description |
Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
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Reporting group description |
Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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15 Mar 2018 |
Following changes were made: Updated department name for the Pharmacovigilance Global Safety Expert; updated the planned trial period and planned trial calendar information; updated description of the need for a physical examination or assessment of health in the case of a rescheduled Visit 1; clarified concomitant medications and other therapies; updated the assay method used to measure anti-tetanus antibodies; addition of references to the Adverse event of special interest (AESI) of generalised seizures and to the AESI of Kawasaki disease.
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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. | |||
| None reported | |||
