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

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ClinicalTrials.gov Identifier: NCT01410474
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Bacterial Meningitis
Intervention: Biological: Meningococcal ACWY conjugate vaccine

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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


  Other Adverse Events


  Limitations and Caveats

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

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
First Submitted: August 3, 2011
First Posted: August 5, 2011
Results First Submitted: March 12, 2013
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014