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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

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
1a - rMenB+OMV NZ and routine vaccines
1b - rMenB+OMV NZ and routine vaccines
2a - Routine and rMenB+OMV NZ vaccines
2b - rMenB+OMV NZ and routine vaccines
3a - rMenB+OMV NZ and routine vaccines
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
4a- rMenB+OMV NZ and routine vaccines
4b - rMenB+OMV NZ and routine vaccines
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring toddler, Meningococcal disease, prevention, vaccination

Eligibility Criteria

365 Days - 394 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Altenburger
  • Grässl
  • Häckel
  • Prieler
  • Maurer
  • Angermayr
  • Sommer
  • Site 27
  • Site 19
  • Site 22
  • Site 12
  • Fakulta vojenskeho zdravotnictví
  • Site 28
  • Site 13
  • Site 25
  • Site 21
  • Site 10
  • Site 24
  • Site 18
  • Site 17
  • Site 16
  • Site 26
  • Site 23
  • Site 30
  • Site 31
  • Site 32
  • Site 34
  • Site 35
  • Site 45
  • Site 46
  • Site 47
  • Site 49
  • Site 50
  • Site 51
  • Site 52
  • Site 53
  • Site 33
  • Site 48
  • Site 99
  • Site 92
  • Site 95
  • Site 64
  • Site 58
  • Site 57
  • Site 80
  • Site 83
  • Site 97
  • Site 96
  • Site 91
  • Site 81
  • Site 65
  • Site 94
  • Dipartimento di Scienze della Salute
  • Universita degli Studi di Messina, Policlinico G. Martino
  • Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
  • Pediatria dell' Ospedale Sacco
  • Ospedale Maggiore di Novara
  • Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
  • ASL/TA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

12B12M (1a)

12B13M (1b)

12M13B15B (2a)

12M12B14B (2b)

12B12M (3a)

12B13M (3b)

12B12M_C (4a)

12B13M_C (4b)

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
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
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
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)
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)
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)
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
February 18, 2009
Last Updated
March 2, 2015
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00847145
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
toddler, Meningococcal disease, prevention, vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12B12M (1a)
Arm Type
Experimental
Arm Description
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.
Arm Title
12B13M (1b)
Arm Type
Experimental
Arm Description
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.
Arm Title
12M13B15B (2a)
Arm Type
Experimental
Arm Description
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.
Arm Title
12M12B14B (2b)
Arm Type
Experimental
Arm Description
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.
Arm Title
12B12M (3a)
Arm Type
Experimental
Arm Description
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.
Arm Title
12B13M (3b)
Arm Type
Experimental
Arm Description
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.
Arm Title
12B12M_C (4a)
Arm Type
Experimental
Arm Description
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.
Arm Title
12B13M_C (4b)
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
1a - rMenB+OMV NZ and routine vaccines
Intervention Description
One dose of rMenB vaccine and routine vaccine at study month 12.
Intervention Type
Biological
Intervention Name(s)
1b - rMenB+OMV NZ and routine vaccines
Intervention Description
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
Intervention Type
Biological
Intervention Name(s)
2a - Routine and rMenB+OMV NZ vaccines
Intervention Description
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
Intervention Type
Biological
Intervention Name(s)
2b - rMenB+OMV NZ and routine vaccines
Intervention Description
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
Intervention Type
Biological
Intervention Name(s)
3a - rMenB+OMV NZ and routine vaccines
Intervention Description
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Intervention Type
Biological
Intervention Name(s)
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Intervention Description
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
Intervention Type
Biological
Intervention Name(s)
4a- rMenB+OMV NZ and routine vaccines
Intervention Description
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Intervention Type
Biological
Intervention Name(s)
4b - rMenB+OMV NZ and routine vaccines
Intervention Description
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Primary Outcome Measure Information:
Title
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Description
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.
Time Frame
one month after the booster (fourth) dose
Secondary Outcome Measure Information:
Title
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Description
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.
Time Frame
one month after booster (fourth) dose
Title
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Description
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).
Time Frame
one month after booster (fourth) vaccination.
Title
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Description
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.
Time Frame
one month after third vaccination and pre dose fourth (booster) vaccination
Title
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Description
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.
Time Frame
One month post vaccination and pe-booster (fourth) dose vaccination
Title
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
Description
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.
Time Frame
one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
Title
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
Description
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.
Time Frame
One month after the second dose.
Title
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
Description
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.
Time Frame
One month after the second dose.
Title
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
Description
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).
Time Frame
One month after the fourth (booster) dose.
Title
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
Description
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.
Time Frame
One month after the first dose and one month after the second dose.
Title
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
Description
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).
Time Frame
One month after the fourth (booster) dose.
Title
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Description
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.
Time Frame
From day 1 to day 7 after each rMenB+OMV NZ vaccination.
Title
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Description
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).
Time Frame
From day 1 to day 7 after each rMenB+MV NZ vaccination.
Title
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
Description
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.
Time Frame
From day 1 to day 7 after MMRV vaccination.
Title
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Description
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.
Time Frame
From day 8 to day 28 after MMRV vaccination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
365 Days
Maximum Age & Unit of Time
394 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Altenburger
City
Eisenstadt
ZIP/Postal Code
7000
Country
Austria
Facility Name
Grässl
City
Hall in Tirol
ZIP/Postal Code
6060
Country
Austria
Facility Name
Häckel
City
Kirchdorf
ZIP/Postal Code
4560
Country
Austria
Facility Name
Prieler
City
Neufeld a.d. Leitha
ZIP/Postal Code
2491
Country
Austria
Facility Name
Maurer
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Angermayr
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Sommer
City
Wien
ZIP/Postal Code
1230
Country
Austria
Facility Name
Site 27
City
Boskovice
ZIP/Postal Code
680 01
Country
Czech Republic
Facility Name
Site 19
City
Brno
ZIP/Postal Code
628 00
Country
Czech Republic
Facility Name
Site 22
City
Chomutov
ZIP/Postal Code
430 03
Country
Czech Republic
Facility Name
Site 12
City
Havlíčkův Brod
ZIP/Postal Code
580 22
Country
Czech Republic
Facility Name
Fakulta vojenskeho zdravotnictví
City
Hradec Králové
ZIP/Postal Code
500 01
Country
Czech Republic
Facility Name
Site 28
City
Hranice I-mesto
ZIP/Postal Code
753 01
Country
Czech Republic
Facility Name
Site 13
City
Humpolec
ZIP/Postal Code
396 01
Country
Czech Republic
Facility Name
Site 25
City
Kladno 2
ZIP/Postal Code
272 00
Country
Czech Republic
Facility Name
Site 21
City
Kolín
ZIP/Postal Code
280 02
Country
Czech Republic
Facility Name
Site 10
City
Liberec
ZIP/Postal Code
460 15
Country
Czech Republic
Facility Name
Site 24
City
Litomerice
ZIP/Postal Code
412 01
Country
Czech Republic
Facility Name
Site 18
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czech Republic
Facility Name
Site 17
City
Ostrava
ZIP/Postal Code
702 00
Country
Czech Republic
Facility Name
Site 16
City
Plzeň
ZIP/Postal Code
305 99
Country
Czech Republic
Facility Name
Site 26
City
Rumburk
ZIP/Postal Code
408 01
Country
Czech Republic
Facility Name
Site 23
City
Usti nad Labem
ZIP/Postal Code
400 01
Country
Czech Republic
Facility Name
Site 30
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
Site 31
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Site 32
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Site 34
City
Järvenpää
ZIP/Postal Code
04400
Country
Finland
Facility Name
Site 35
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Site 45
City
Kotka
ZIP/Postal Code
48600
Country
Finland
Facility Name
Site 46
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Site 47
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
Site 49
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Site 50
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Site 51
City
Seinäjoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Site 52
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Site 53
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Site 33
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
Site 48
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
Site 99
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Site 92
City
Espelkamp
ZIP/Postal Code
32339
Country
Germany
Facility Name
Site 95
City
Freising
ZIP/Postal Code
85354
Country
Germany
Facility Name
Site 64
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Site 58
City
Lauffen
ZIP/Postal Code
74348
Country
Germany
Facility Name
Site 57
City
Marbach a. N.
ZIP/Postal Code
71672
Country
Germany
Facility Name
Site 80
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Site 83
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Site 97
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Site 96
City
München
ZIP/Postal Code
81475
Country
Germany
Facility Name
Site 91
City
Műnchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Site 81
City
Porta Westfalica
ZIP/Postal Code
32457
Country
Germany
Facility Name
Site 65
City
Schwieberdingen
ZIP/Postal Code
71701
Country
Germany
Facility Name
Site 94
City
Weilheim
ZIP/Postal Code
82362
Country
Germany
Facility Name
Dipartimento di Scienze della Salute
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita degli Studi di Messina, Policlinico G. Martino
City
Messina
Country
Italy
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pediatria dell' Ospedale Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale Maggiore di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
ASL/TA
City
Taranto
ZIP/Postal Code
74100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31110098
Citation
Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
Results Reference
derived
PubMed Identifier
23324563
Citation
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. doi: 10.1016/S0140-6736(12)61961-8. Erratum In: Lancet. 2013 Mar 9;381(9869):804.
Results Reference
derived

Learn more about this trial

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

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