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Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00616421
First received: January 31, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.


Condition Intervention Phase
Meningococcal Infections
Biological: MenACWY-CRM
Biological: Licensed meningococcal ACWY vaccine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

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


  • Number of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

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



Secondary Outcome Measures:
  • Number Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

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


  • Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

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


  • Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.

  • Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

  • Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.

  • Number of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.

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


  • Number of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]

    The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.

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


  • Number of Subjects With hSBA GMTs, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
    The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.

  • Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age [ Time Frame: Study days 1 to 7 ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group.

  • Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age [ Time Frame: Study days 1 to 7 ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group.


Enrollment: 2907
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM (1 dose)
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.
Biological: MenACWY-CRM
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
Other Name: Menveo
Active Comparator: Licensed polysaccharide vaccine
1 injection of a licensed meningococcal ACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1
Biological: Licensed meningococcal ACWY vaccine
1 injection of the licensed meningococcal ACWY was administered intramuscularly
Other Name: Menactra
Experimental: MenACWY-CRM (2 doses)
2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.
Biological: MenACWY-CRM
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
Other Name: Menveo

  Eligibility

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

Inclusion Criteria:

  • healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
  • who are available for all visits and telephone calls scheduled for the study
  • who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

  • whose parent or legal guardian is unwilling or unable to give written informed consent
  • who had a previous or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • who have received any investigational agents or vaccines within 90 days prior to enrollment
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
  • who have a history of anaphylaxis, serious vaccine reactions
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
  • 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: NCT00616421

  Show 68 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00616421     History of Changes
Other Study ID Numbers: V59P20, 11278
Study First Received: January 31, 2008
Results First Received: February 28, 2011
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
vaccine
children
healthy
meningitis
meningococcal
prevention of meningococcal disease serogroups ACWY
Menveo

Additional relevant MeSH terms:
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Lactitol
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014