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
  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 vaccines
Biological: 1b - rMenB+OMV NZ and routine vaccines
Biological: 2a - Routine and rMenB+OMV NZ vaccines
Biological: 2b - rMenB+OMV NZ and routine vaccines
Biological: 3a - rMenB+OMV NZ and routine vaccines
Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Biological: 4a- rMenB+OMV NZ and routine vaccines
Biological: 4b - rMenB+OMV NZ and routine vaccines
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:
  • 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.


Secondary Outcome Measures:
  • 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.


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: 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.
Biological: 1a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and routine vaccine at study month 12.
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.
Biological: 1b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
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.
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.
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.
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.
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.
Biological: 3a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
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.
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.
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.
Biological: 4a- rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
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.
Biological: 4b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

  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

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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
Results First Received: February 3, 2015
Last Updated: March 2, 2015
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 August 02, 2015