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Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00262028
First received: December 2, 2005
Last updated: January 12, 2016
Last verified: January 2016
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Prevention
Condition: Prevention of Meningococcal Disease
Interventions: Biological: MenACWY-CRM Vaccine
Biological: MenACWY-PS 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 recruited from a single center.

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

Reporting Groups
  Description
MenACWY (2-5 Years Old) Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
MenACWY-PS (2-5 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
MenACWY (6-10 Years Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY-PS (6-10 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
MenACWY (12-15 Months Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY+PnC (12-15 Months) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
MenACWY (16-23 Months) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY+DTaP (16-23 Months) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
MenACWY-PS (3-5 Years Old) Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.

Participant Flow:   Overall Study
    MenACWY (2-5 Years Old)     MenACWY-PS (2-5 Years Old)     MenACWY (6-10 Years Old)     MenACWY-PS (6-10 Years Old)     MenACWY (12-15 Months Old)     MenACWY+PnC (12-15 Months)     MenACWY (16-23 Months)     MenACWY+DTaP (16-23 Months)     MenACWY-PS (3-5 Years Old)  
STARTED     152     153     157     157     74     73     71     73     100  
COMPLETED     128     126     137     134     62     60     59     55     81  
NOT COMPLETED     24     27     20     23     12     13     12     18     19  
Withdrawal by Subject                 6                 3                 6                 5                 2                 3                 5                 7                 2  
Lost to Follow-up                 7                 7                 5                 5                 4                 3                 3                 5                 6  
Administrative Reason                 11                 14                 9                 12                 6                 7                 4                 6                 10  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Unable to classify                 0                 3                 0                 0                 0                 0                 0                 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.
No text entered.

Reporting Groups
  Description
MenACWY (2-5 Years Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY-PS (2-5 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
MenACWY (6-10 Years Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
MenACWY-PS (6-10 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
MenACWY (12-15 Months Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY-PnC (12-15 Months Old) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
MenACWY (16-23 Months Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
MenACWY+DTaP (16-23 Months Old) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
MenACWY+PS (3-5 YearsOld) Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
Total Total of all reporting groups

Baseline Measures
    MenACWY (2-5 Years Old)     MenACWY-PS (2-5 Years Old)     MenACWY (6-10 Years Old)     MenACWY-PS (6-10 Years Old)     MenACWY (12-15 Months Old)     MenACWY-PnC (12-15 Months Old)     MenACWY (16-23 Months Old)     MenACWY+DTaP (16-23 Months Old)     MenACWY+PS (3-5 YearsOld)     Total  
Number of Participants  
[units: participants]
  152     153     157     157     74     73     71     73     100     1010  
Age  
[units: years]
Mean (Standard Deviation)
  3.3  (1.2)     3.3  (1.2)     8.0  (1.5)     8.0  (1.4)     NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   5.7  (2.7)  
Age  
[units: months]
Mean (Standard Deviation)
  NA [2]   NA [2]   NA [2]   NA [2]   12.2  (0.5)     12.2  (0.5)     18.2  (1.3)     18.2  (1.4)     52.6  (11.4)     24.7  (17.5)  
Gender  
[units: participants]
                   
Female     66     79     80     78     NA [1]   NA [4]   NA [4]   NA [4]   NA [4]   NA [3]
Male     86     74     77     79     NA [4]   NA [4]   NA [4]   NA [4]   NA [4]   NA [3]
Gender  
[units: participants]
                   
Female     NA [2]   NA [2]   NA [2]   NA [2]   30     29     31     36     51     NA [3]
Male     NA [2]   NA [2]   NA [2]   NA [2]   44     44     40     37     49     NA [3]
[1] Data are reported in a separate table
[2] Data are reported in the previous table
[3] Total not calculated because data are not available (NA) in one or more arms.
[4] reported in a separate table



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

2.  Secondary:   Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

3.  Secondary:   Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

4.  Secondary:   hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

5.  Secondary:   hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

6.  Secondary:   hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine   [ Time Frame: 1 month post vaccination (Day 29) ]

7.  Secondary:   Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine   [ Time Frame: 12 months post vaccination (Day 360) ]

8.  Secondary:   hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine   [ Time Frame: 12 months post vaccination (Day 360) ]

9.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years   [ Time Frame: Day 1 to 7 post vaccination ]

10.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months   [ Time Frame: Day 1 to 7 post vaccination ]

11.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years   [ Time Frame: Day 1- Day 360 (throughout the study) ]

12.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months   [ Time Frame: Day 1- Day 360 (Throughout the study) ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00262028     History of Changes
Other Study ID Numbers: V59P8
Study First Received: December 2, 2005
Results First Received: August 30, 2013
Last Updated: January 12, 2016
Health Authority: United States: Food and Drug Administration