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: March 2, 2015
Last verified: March 2015

February 18, 2009
March 2, 2015
February 2009
August 2010   (final data collection date for primary outcome measure)
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination [ Time Frame: one month after the booster (fourth) dose ] [ Designated as safety issue: No ]
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
  • 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 ]
Complete list of historical versions of study NCT00847145 on ClinicalTrials.gov Archive Site
  • Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination [ Time Frame: one month after booster (fourth) dose ] [ Designated as safety issue: Yes ]

    Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.

    The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection.

  • The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination [ Time Frame: one month after booster (fourth) vaccination. ] [ Designated as safety issue: No ]
    The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
  • Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) [ Time Frame: one month after third vaccination and pre dose fourth (booster) vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
  • Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) [ Time Frame: One month post vaccination and pe-booster (fourth) dose vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
  • Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) [ Time Frame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.
  • SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule [ Time Frame: One month after the second dose. ] [ Designated as safety issue: No ]
    The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.
  • Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule [ Time Frame: One month after the second dose. ] [ Designated as safety issue: No ]
    The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.
  • ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months [ Time Frame: One month after the fourth (booster) dose. ] [ Designated as safety issue: No ]
    The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
  • ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers [ Time Frame: One month after the first dose and one month after the second dose. ] [ Designated as safety issue: No ]
    The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.
  • Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months [ Time Frame: One month after the fourth (booster) dose. ] [ Designated as safety issue: No ]
    The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
  • Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age [ Time Frame: From day 1 to day 7 after each rMenB+OMV NZ vaccination. ] [ Designated as safety issue: No ]
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.
  • Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination [ Time Frame: From day 1 to day 7 after each rMenB+MV NZ vaccination. ] [ Designated as safety issue: No ]
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).
  • Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age [ Time Frame: From day 1 to day 7 after MMRV vaccination. ] [ Designated as safety issue: No ]
    Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
  • Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age [ Time Frame: From day 8 to day 28 after MMRV vaccination. ] [ Designated as safety issue: No ]
    Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
  • 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 ]
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 vaccines
    One dose of rMenB vaccine and routine vaccine at study month 12.
  • Biological: 1b - rMenB+OMV NZ and routine vaccines
    One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
  • Biological: 2a - Routine and rMenB+OMV NZ vaccines
    One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
  • Biological: 2b - rMenB+OMV NZ and routine vaccines
    Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
  • Biological: 3a - rMenB+OMV NZ and routine vaccines
    One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
  • Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
    One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
  • Biological: 4a- rMenB+OMV NZ and routine vaccines
    One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
  • Biological: 4b - rMenB+OMV NZ and routine vaccines
    One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
  • Experimental: 12B12M (1a)
    Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
    Intervention: Biological: 1a - rMenB+OMV NZ and routine vaccines
  • Experimental: 12B13M (1b)
    Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
    Intervention: Biological: 1b - rMenB+OMV NZ and routine vaccines
  • Experimental: 12M13B15B (2a)
    Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
    Intervention: Biological: 2a - Routine and rMenB+OMV NZ vaccines
  • Experimental: 12M12B14B (2b)
    Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
    Intervention: Biological: 2b - rMenB+OMV NZ and routine vaccines
  • Experimental: 12B12M (3a)
    Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
    Intervention: Biological: 3a - rMenB+OMV NZ and routine vaccines
  • Experimental: 12B13M (3b)
    Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
    Intervention: Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
  • Experimental: 12B12M_C (4a)
    Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
    Intervention: Biological: 4a- rMenB+OMV NZ and routine vaccines
  • Experimental: 12B13M_C (4b)
    Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
    Intervention: Biological: 4b - rMenB+OMV NZ and routine vaccines
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. Erratum in: Lancet. 2013 Mar 9;381(9869):804.

*   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
March 2015

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