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: January 14, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Meningococcal Meningitis
Human Papillomavirus Infection
Pertussis
Tetanus
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Biological: Tdap Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With hSBA Seroresponse [ Time Frame: 1 month postvaccination ] [ 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 Tdap vaccine and a 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 postvaccination ] [ 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 of Antipertussis Toxin [Anti-PT], Antifilamentous Hemagglutinin [Anti-FHA], and Antipertactin [Anti-PRN] [ Time Frame: 1 month postvaccination ] [ 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


Secondary Outcome Measures:
  • Effect of Concomitant and Sequential Vaccination on hSBA GMTs for A, C, W, and Y Serogroups [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    To demonstrate that 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 after 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.) 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 after 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 for A, C, W, and Y Serogroups [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    To demonstrate that immune responses to MenACWY, as measured by hSBA titer ≥ 1:8, 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 postvaccination ] [ Designated as safety issue: No ]
    To demonstrate that 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 for Diphtheria and Tetanus [ Time Frame: 1 month postvaccination ] [ 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 of Pertussis Antigens [ Time Frame: 1 month postvaccination ] [ 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.

  • Percentage of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN [ Time Frame: 1 month postvaccination ] [ 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.


Enrollment: 1620
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
One dose of vaccine administered intramuscularly
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
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
One dose of vaccine administered intramuscularly
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
Biological: Tdap Vaccine
One dose of vaccine administered intramuscularly

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518180

Locations
Costa Rica
San Jose, Costa Rica
San Jose, Costa Rica
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00518180     History of Changes
Other Study ID Numbers: V59P18
Study First Received: August 17, 2007
Results First Received: March 19, 2010
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration
Costa Rica: Ministry of Health Costa Rica

Keywords provided by Novartis:
Meningococcal
meningitis
vaccine
adolescents

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Whooping Cough
Tetanus
Tetany
Warts
Papillomavirus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014