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Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01410474
First received: August 3, 2011
Last updated: September 16, 2014
Last verified: September 2014
History of Changes
Results First Received: March 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Bacterial Meningitis
Intervention: Biological: Meningococcal ACWY conjugate vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at three study centres in Taiwan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were included in the trial.

Reporting Groups
  Description
2-10 Years Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11-18 Years Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.

Participant Flow:   Overall Study
    2-10 Years     11-18 Years  
STARTED     173     168  
COMPLETED     173     167  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was done on all the enrolled subjects.

Reporting Groups
  Description
2-10 Years Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11-18 Years Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Total Total of all reporting groups

Baseline Measures
    2-10 Years     11-18 Years     Total  
Number of Participants  
[units: participants]
 		  173     168     341  
Age  
[units: Years]
Mean (Standard Deviation) 		  6.3  (2.6)     14.0  (2.2)     10.1  (4.5)  
Gender  
[units: Subjects]
 		     
Female     92     88     180  
Male     81     80     161  



  Outcome Measures
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1.  Primary:   Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and Day 29 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group   [ Time Frame: Day 1 and Day 29 ]
  Show Outcome Measure 2

3.  Secondary:   Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and 29 ]
  Show Outcome Measure 3

4.  Secondary:   Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and Day 29 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and 29 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years   [ Time Frame: From day 1 through day 7 postvaccination ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years   [ Time Frame: From day 1 through day 7 postvaccination ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01410474     History of Changes
Other Study ID Numbers: V59_49
Study First Received: August 3, 2011
Results First Received: March 12, 2013
Last Updated: September 16, 2014
Health Authority: Taiwan : Food and Drug Administration