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Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00856297
First received: March 2, 2009
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: October 24, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Meningococcal Meningitis
Interventions: Biological: MenACWY-CRM conjugate vaccine
Biological: Licensed comparator

  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 19 sites in US.

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
MenACWY-CRM Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
Naive Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

Participant Flow:   Overall Study
    MenACWY-CRM     Licensed Comparator     Naive     MenACWY-CRM/MenACWY-CRM     Licensed Comparator /MenACWY-CRM  
STARTED     131     76     107     44     31  
COMPLETED     129     76     107     44     31  
NOT COMPLETED     2     0     0     0     0  
Unable to classify                 2                 0                 0                 0                 0  



  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.
Enrolled population

Reporting Groups
  Description
MenACWY-CRM Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Licensed Comparator Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
Naive Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
MenACWY-CRM/MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
Licensed Comparator /MenACWY-CRM Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Total Total of all reporting groups

Baseline Measures
    MenACWY-CRM     Licensed Comparator     Naive     MenACWY-CRM/MenACWY-CRM     Licensed Comparator /MenACWY-CRM     Total  
Number of Participants  
[units: participants]
  131     76     107     44     31     389  
Age  
[units: years]
Mean ± Standard Deviation
  19.4  ± 2.4     18.8  ± 2.4     19.3  ± 2.4     19.0  ± 1.9     19.7  ± 2.3     19.2  ± 2.3  
Gender  
[units: participants]
           
Female     65     29     68     21     13     196  
Male     66     47     39     23     18     193  



  Outcome Measures
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1.  Primary:   Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine   [ Time Frame: 21 months, 3 years and 5 years postvaccination ]

2.  Secondary:   Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine   [ Time Frame: 21 months, 3 years and 5 years postvaccination ]

3.  Secondary:   hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine   [ Time Frame: 21 months, 3 years and 5 years postvaccination ]

4.  Secondary:   Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8   [ Time Frame: day 1 ]

5.  Secondary:   hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination   [ Time Frame: day 1 ]

6.  Secondary:   Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine   [ Time Frame: 1 month post booster vaccination ]

7.  Secondary:   Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine   [ Time Frame: 2 years postvaccination ]

8.  Secondary:   Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine   [ Time Frame: 2 years postvaccination ]

9.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events   [ Time Frame: Day 1 to Day 7 ]

10.  Secondary:   Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator   [ Time Frame: Day 1 to 5 years ]

11.  Secondary:   Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine   [ Time Frame: 28 days postvaccination ]


  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
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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 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


Publications of Results:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00856297     History of Changes
Other Study ID Numbers: V59P13E1
Study First Received: March 2, 2009
Results First Received: October 24, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration