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

March 2, 2009
December 17, 2013
February 2009
November 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
21 months, 3, 5 and 7 years persistence of bactericidal antibodies antibody response [ Time Frame: 21 months, 3, 5 and 7 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856297 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.
  • hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine [ Time Frame: 2 years postvaccination ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects Reporting Solicited Local and Systemic Adverse Events [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
Not Provided
 
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Meningitis
  • Biological: MenACWY-CRM conjugate vaccine
  • Biological: Licensed comparator
    Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
  • 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.
    Intervention: 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.
    Intervention: Biological: Licensed comparator
  • Naive
    Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
    Interventions:
    • Biological: MenACWY-CRM conjugate vaccine
    • Biological: Licensed comparator
  • 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.
    Intervention: 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.
    Interventions:
    • Biological: MenACWY-CRM conjugate vaccine
    • Biological: Licensed comparator
Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents. Hum Vaccin. 2010 Nov;6(11):881-7. Epub 2010 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856297
V59P13E1
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Novartis
Study Chair: Novartis Vaccines Novartis
Novartis
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP