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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018732
First Posted: November 25, 2009
Last Update Posted: July 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
November 18, 2009
November 25, 2009
August 9, 2011
September 13, 2011
July 15, 2015
January 2010
July 2010   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination) ]
    Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
  • Geometric Mean Titer After Booster Vaccination [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ]
    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
5 years post for persistence of antibodies; 7 and 28 days post-boost for immunogenicity response. [ Time Frame: 7 and 28 days postvaccination ]
Complete list of historical versions of study NCT01018732 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination ) ]
    Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
  • Geometric Mean Titer at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination ) ]
    Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
  • Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ]
    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
  • Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ]
    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
  • Geometric Mean Ratio After Booster Vaccination [ Time Frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination) ]
    Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1
  • Percentage of Subjects With hSBA Seroresponse After Booster Vaccination [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ]
    For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
  • Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination [ Time Frame: Up to Day 7 ]
    Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Evaluate persistence after 5 years and response after 1 dose plus all pairwise immunogenicity data. [ Time Frame: 7 and 28 days postvaccination ]
Not Provided
Not Provided
 
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). 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.
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Meningococcal Disease
  • Meningococcal Meningitis
Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
All subjects will have blood draws at Day 1, Day 8, and Day 29.
  • Experimental: I: MenACWY-CRM vaccine
    Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study.
    Intervention: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
  • Experimental: II: Licensed Polysaccharide Meningococcal vaccine
    Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study.
    Intervention: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
  • Experimental: III: Meningococcal Naive
    Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.
    Intervention: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
  • Female subjects were to be negative for pregnancy

Exclusion Criteria:

  • History of meningococcal disease
  • Receipt of any meningococcal vaccine outside of parent study (V59P6)
  • Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
  • receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
  • any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
Sexes Eligible for Study: All
16 Years to 23 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01018732
V59P6E1
No
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Novartis
Not Provided
Novartis
July 2015

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