Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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: NCT00847145

  Show 59 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  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: 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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 20, 2014