Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00518180
First received: August 17, 2007
Last updated: April 18, 2016
Last verified: April 2016

August 17, 2007
April 18, 2016
July 2007
April 2008   (final data collection date for primary outcome measure)
  • Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse [ Time Frame: 1 month post MenACWY vaccination ] [ Designated as safety issue: No ]

    Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.

    Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

  • Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
  • Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Immunogenicity of MenACWY vaccine when given concomitantly with Tdap and HPV vaccines at different schedules
Complete list of historical versions of study NCT00518180 on ClinicalTrials.gov Archive Site
  • Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups [ Time Frame: 1 month post MenACWY vaccination ] [ Designated as safety issue: No ]
    The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
  • Percentage of Subjects With Anti-HPV Seroconversion [ Time Frame: 1 month post third HPV vaccination ] [ Designated as safety issue: No ]
    To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
  • Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay [ Time Frame: 1 month post third HPV vaccination ] [ Designated as safety issue: No ]
    To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
  • Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups [ Time Frame: 1 month post MenACWY vaccination ] [ Designated as safety issue: No ]
    The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
  • The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
  • Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
  • Geometric Mean Titers (GMT) of Pertussis Antigens [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
  • Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN [ Time Frame: 1 month post Tdap vaccination ] [ Designated as safety issue: No ]
    To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
  • Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
    Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
  • Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
    Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
  • Immunogenicity of Novartis MenACWY Conjugate Vaccine when given with concomitant vaccines at different schedules to healthy adolescents
  • Safety and tolerability of Novartis MenACWY when given with concomitant vaccines at different schedules to healthy adolescents
Not Provided
Not Provided
 
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningococcal Meningitis
  • Human Papillomavirus Infection
  • Pertussis
  • Tetanus
  • Biological: Novartis Meningococcal ACWY Conjugate Vaccine
    One dose of vaccine administered intramuscularly
  • Biological: Tdap Vaccine
    One dose of vaccine administered intramuscularly
  • Experimental: MenACWY + Tdap + HPV
    Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
    Intervention: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
  • Experimental: MenACWY →Tdap → HPV
    Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8
    Intervention: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
  • Experimental: Tdap →MenACWY → HPV
    Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
    Intervention: Biological: Tdap Vaccine
Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1620
October 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adolescents 11-18 years of age
  • virgins (both male and female) with no intention of becoming sexually active during the study period
  • who have been properly vaccinated against diphtheria, tetanus, pertussis

Exclusion Criteria:

  • who had a previous confirmed or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine
  • who have received prior human papillomavirus (HPV) vaccine;
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired
  • who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
  • who have Down's syndrome or other known cytogenic disorders;
Both
11 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Costa Rica
 
NCT00518180
V59P18
No
Not Provided
Not Provided
Novartis Vaccines
Novartis Vaccines
Not Provided
Study Director: Novartis Vaccines and Diagnostics Novartis
Novartis
April 2016

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