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

February 18, 2009
October 21, 2011
February 2009
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00847145 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Disease
  • Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
    1 dose of routine infant vaccinations plus 2 doses of rMenB+OMV NZ
  • 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
  • Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
    1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Experimental: 1
    Intervention: Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
  • Experimental: 2
    Intervention: Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
  • Experimental: 3
    Intervention: Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
  • Experimental: 4
    Intervention: Biological: 2b - rMenB+OMV NZ and routine infant vaccinations
  • Experimental: 5
    Intervention: Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
  • Experimental: 6
    Intervention: Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Experimental: 7
    Intervention: Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
  • Experimental: 8
    Intervention: Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2249
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
365 Days to 394 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Finland,   Germany,   Italy
 
NCT00847145
V72P13E1, 2008-006301-17
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP