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Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00310817
First received: April 3, 2006
Last updated: October 6, 2015
Last verified: October 2015
  Purpose
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Condition Intervention Phase
Meningococcal Meningitis
Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Biological: MenACWY polysaccharide vaccine
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 28 days after first vaccination. ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.


Secondary Outcome Measures:
  • Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 28 days after first vaccination. ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 28 days after first vaccination. ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 6 months after first vaccination and 12 months after first vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 21 days after second vaccination ] [ Designated as safety issue: No ]
    Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age [ Time Frame: 12 months after second vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age [ Time Frame: 12 months after second vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age [ Time Frame: 12 months after second vaccination ] [ Designated as safety issue: No ]
    Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.

  • Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [ Time Frame: From day 1 through day 7 after first or second vaccination(s) ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.

  • Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination [ Time Frame: 28 days after first vaccination and 21 days after second vaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.


Enrollment: 623
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM(Ad+) 12 to 35 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Experimental: MenACWY-CRM(Ad-) 12 to 35 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Experimental: MenACWY-CRM(Ad-) 36 to 59 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337.
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Active Comparator: MenACWY-PS (36 to 59 Months)
Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337.
Biological: MenACWY polysaccharide vaccine

  Eligibility

Ages Eligible for Study:   12 Months to 59 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy 12-<60 month old children;

Exclusion Criteria:

  • subjects who have previously received any meningococcal vaccine
  • subjects with any serious acute or chronic progressive disease
  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: NCT00310817

Locations
Finland
University of Tampere Medical School
Tampere, Finland
Poland
Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow
Samodzielny ZOZ, Lubartów, Poland
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00310817     History of Changes
Other Study ID Numbers: V59P7  EUDRACT NUMBER: 2004-001896-21 
Study First Received: April 3, 2006
Results First Received: August 29, 2013
Last Updated: October 6, 2015
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Poland: CEBK (Central Register of Clinical Trials)

Keywords provided by Novartis:
meningitis
children
vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016