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

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ClinicalTrials.gov Identifier: NCT00856297
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : January 22, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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Brief Summary:
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Biological: MenACWY-CRM conjugate vaccine Biological: Licensed comparator Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine
Study Start Date : February 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: MenACWY-CRM conjugate vaccine
Active Comparator: 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.
 Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Naive
Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
 Biological: MenACWY-CRM conjugate vaccine
Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Experimental: 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.
 Biological: MenACWY-CRM conjugate vaccine
Experimental: 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.
 Biological: MenACWY-CRM conjugate vaccine
Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.


Secondary Outcome Measures :
  1. 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 ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

  2. 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 ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

  3. Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 [ Time Frame: day 1 ]
    Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  4. hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination [ Time Frame: day 1 ]
    Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

  5. 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 ]
    Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  6. 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 ]
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  7. Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine [ Time Frame: 2 years postvaccination ]
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

  8. Number of Subjects Reporting Solicited Local and Systemic Adverse Events [ Time Frame: Day 1 to Day 7 ]
    Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

  9. 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 ]
    Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

  10. 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 ]
    Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects enrolled in V59P13:

  • healthy subjects who have completed the V59P13 study.

Naïve subjects:

  • healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).

Exclusion Criteria:

Subjects who had completed the V59P13 study:

  • who received any meningococcal vaccine after the V59P13 trial;
  • who have had previous confirmed or suspected disease caused by N. meningitidis;
  • who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
  • subjects with any serious, acute or chronic progressive disease.

Naïve subjects:

  • who previously received any meningococcal vaccine;
  • who have had previous confirmed or suspected disease caused by N. meningitidis;
  • who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
  • subjects with any serious, acute or chronic progressive disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856297


Locations
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Sponsors and Collaborators
Novartis Vaccines
GlaxoSmithKline
Investigators
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Study Chair: Novartis Vaccines Novartis
More Information
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Publications of Results:

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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00856297    
Other Study ID Numbers: V59P13E1
First Posted: March 5, 2009    Key Record Dates
Results First Posted: January 22, 2014
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal
ACWY
Conjugate Vaccine
 Meningitis
Adolescents
Persistence
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs