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Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00847145
First received: February 18, 2009
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers


Condition Intervention Phase
Meningococcal Disease
 Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
Biological: 2b - rMenB+OMV NZ and routine infant vaccinations
Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
 Phase 3

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, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity assessed by serum bactericidal assay (SBA) following a booster dose of Meningococcal B vaccine with or without concomitant MMRV vaccination, in toddlers who were previously primed with 3 doses of Meningococcal B vaccine as infants. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of a booster dose of MenB vaccine with and without MMRV, safety and tolerability of a two-dose catch-up regimen of MenB vaccine, and safety and tolerability of a single dose of MenB vaccine in toddlers. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Immunogenicity of a two-dose catch-up schedule of Meningococcal B vaccine given at 13 and 15 months or 12 and 14 months to naïve toddlers. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-inferiority of immune responses to MMRV vaccination, when administered concomitantly with the booster dose of Meningococcal B vaccine to the immune responses of MMRV when given alone. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Immune response following a booster dose of Meningococcal B vaccine with or without concomitant MMRV vaccination, as measured by SBA GMTs and percentage of subjects with SBA titers ≥ 1:5. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Persistence of bactericidal antibodies in infants who previously received 3 doses ofMeningococcal B vaccine, as measured by SBA GMTs and the percentage of subjects with SBA titers ≥ 1:5. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Immunological memory in infants who previously received 3 doses of Meningococcal B vaccine. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]

Enrollment: 2249
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 2 Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 3 Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
1 dose of routine infant vaccinations plus 2 doses of rMenB+OMV NZ
Experimental: 4 Biological: 2b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations plus 1 dose of rMenB+OMV NZ
Experimental: 5 Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 6 Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 7 Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 8 Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations

  Eligibility

Ages Eligible for Study:   365 Days to 394 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

Exclusion Criteria:

  • Previous ascertained or suspected disease caused by N. meningitidis;
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • Any serious chronic or progressive disease
  • Known or suspected impairment/ alteration of the immune system,
  • Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847145

  Show 59 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00847145     History of Changes
Other Study ID Numbers: V72P13E1, 2008-006301-17
Study First Received: February 18, 2009
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration
Italy: AIFA
Finland: NAM
Germany: PEI
Czech Republic: SUKL
Austria: Austrian Federal Agency for Safety in Health Care (BSAG)

Keywords provided by Novartis:
toddler
Meningococcal disease
prevention
vaccination

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

ClinicalTrials.gov processed this record on May 16, 2013