Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00329849
First received: May 23, 2006
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age


Condition Intervention Phase
Meningococcal Disease
Biological: Meningococcal ACWY-CRM conjugate vaccine
Biological: Meningococcal ACWY-PS polysaccharide vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: 1 month after vaccination (day 29) ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.

    Seroresponse was defined as:

    1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8;
    2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

  • Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination [ Time Frame: Day 1 to 7 postvaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.


Secondary Outcome Measures:
  • Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: Day 1 and 29 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.

  • The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: Day 1 and 29 ] [ Designated as safety issue: No ]
    The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.

  • Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: Day 181 ] [ Designated as safety issue: No ]
    The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.

  • The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: Day 181 ] [ Designated as safety issue: No ]
    The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS

  • Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS [ Time Frame: Day 1 to 7 postvaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.


Enrollment: 1500
Study Start Date: May 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
Biological: Meningococcal ACWY-CRM conjugate vaccine
MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
Active Comparator: MenACWY-PS
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS)
Biological: Meningococcal ACWY-PS polysaccharide vaccine
MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
  • Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
  • Good health as determined by the clinical judgment of the investigator.

Exclusion Criteria:

Individuals not eligible to be enrolled into the study were those:

  • whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
  • whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period;
  • who had a previous or suspected disease caused by N meningitidis;
  • who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
  • who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
  • who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
  • who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
  • who had received a live viral vaccine within 60 days prior to enrollment;
  • who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment;
  • who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
  • who had epilepsy or any progressive neurological disease;
  • who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
  • who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
  • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
  • receipt of immunostimulants;
  • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
  • common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
  • who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time;
  • who had Down syndrome or other known cytogenic disorders;
  • whose families were planning to leave the area of the study site before the end of the study period;
  • who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00329849

Locations
Argentina
FUNCEI, French 3085
Buenos Aires, Argentina
Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464
Cordoba, Argentina
Hospital de Pediatria "Sor Maria Ludovica", Calle 14 N1631,(1900)
La Plata, Argentina
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines & Diagnostics - Novartis Vaccines & Diagnostics
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00329849     History of Changes
Other Study ID Numbers: V59P10
Study First Received: May 23, 2006
Results First Received: August 30, 2013
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:
Meningitis
children
vaccine
safety
efficacy

Additional relevant MeSH terms:
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 21, 2014