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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
This study has been completed.

First Received on May 16, 2007.   Last Updated on July 29, 2011   History of Changes
Sponsor: Novartis
Collaborator: Novartis Vaccines
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00474526
  Purpose

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants


Condition Intervention Phase
Meningitis, Meningococcal
 Biological: Meningococcal ACWY Conjugate Vaccine
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Resource links provided by NLM:

MedlinePlus related topics: Meningitis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity of four doses of MenACWY ( US subjects) [ Time Frame: 2, 4, 6 and 12 months of age ] [ Designated as safety issue: No ]
    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.

  • To compare the immunogenicity of the fourth dose (US infants received 3 doses at 2, 4 and 6 months) to single dose (US naive infants received one dose at 12 months)of MenACWY [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
    Immunogenicity as measured by the ratio of GMTs,directed against N. meningitidis serogroups A, C, W, and Y


Secondary Outcome Measures:
  • Immunogenicity of three doses of MenACWY (US subjects) [ Time Frame: at 2, 4 and 6 months of age ] [ Designated as safety issue: No ]
    Immunogenicity measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 and ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y (US subjects);

  • To compare the immunogenicity of two doses of MenACWY given to infants (Latin American) at 2 and 6 months of age to three doses of MenACWY given to infants at 2, 4, and 6 months of age [ Time Frame: 2, 4 and 6 months ] [ Designated as safety issue: No ]
    Immunogenicity as measured by hSBA GMTs and by the percentage of subjects with hSBA ≥1:4 and hSBA ≥ 1:8, directed against N. meningitidis serogroups A, C, W, and Y


Enrollment: 4545
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Immuno and safety, MenACWY and concomitant vaccines 2,4,6,12 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 2
Immuno and safety, MenACWY and concomitant vaccines 2,4,6 months; concomitant vaccines at 12 months, MenACWY at 13 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 3
Immuno and safety, concomitant vaccines 2,4,6,12 months; MenACWY at 12 and 15 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 4
Safety, MenACWY and concomitant vaccines 2,4,6,12 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 5
Safety, concomitant vaccines 2,4,6,12 months, MenACWY at 18 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 6
Immuno and safety, MenACWY and concomitant vaccines 2,6,12 months, concomitant vaccines at 4 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 7
Immuno and safety, MenACWY and concomitant vaccines 2,6 months; concomitant vaccines at 4,12 months, MenACWY at 13 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 8
Immuno and safety, concomitant vaccines 2,4,6,12 months; MenACWY at 12 and 15 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 9
Immuno and safety, MenACWY and concomitant vaccines 2,4,6,16 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 10
Immuno and safety, MenACWY and concomitant vaccines 2,4,6 months; concomitant vaccines at 16 months, MenACWY at 17 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 11
Immuno and safety, concomitant vaccines 2,4,6 months; Menveo and concomitant vaccines at 12 and 15 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 12
Safety, MenACWY and concomitant vaccines 2,4,6,12 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.
Experimental: Arm 13
Safety, concomitant vaccines 2,4,6,12 months, MenACWY at 18 months
 Biological: Meningococcal ACWY Conjugate Vaccine
.

  Eligibility

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

Inclusion Criteria:

  • Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion Criteria:

  • Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474526

  Show 63 Study Locations
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis - Vaccines Novartis Vaccines & Diagnostics
  More Information

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00474526     History of Changes
Other Study ID Numbers: V59P14
Study First Received: May 16, 2007
Last Updated: July 29, 2011
Health Authority: United States: Food and Drug Administration;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Colombia: INVIMA

Keywords provided by Novartis:
Meningococcal
meningitis
vaccine
 infants
Meningococcal meningitis
Meningococcal disease

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
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

ClinicalTrials.gov processed this record on February 12, 2012



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