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

Novartis Vaccines2,249 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,249

Conditions

Meningococcal Disease

Interventions

1a - rMenB+OMV NZ and routine vaccinesBIOLOGICAL

One dose of rMenB vaccine and routine vaccine at study month 12.

1b - rMenB+OMV NZ and routine vaccinesBIOLOGICAL

One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.

2a - Routine and rMenB+OMV NZ vaccinesBIOLOGICAL

One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.

Eligibility

Sex: ALLMin age: 365 DaysMax age: 394 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (59)

Outcomes

Primary Outcomes

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.

Time frame: one month after the booster (fourth) dose

Secondary Outcomes

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.

Time frame: one month after booster (fourth) dose

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).

Time frame: one month after booster (fourth) vaccination.

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.

Data from ClinicalTrials.gov

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Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.

3a - rMenB+OMV NZ and routine vaccinesBIOLOGICAL

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinationsBIOLOGICAL

One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.

4a- rMenB+OMV NZ and routine vaccinesBIOLOGICAL

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

4b - rMenB+OMV NZ and routine vaccinesBIOLOGICAL

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

Altenburger

Eisenstadt, Austria

Grässl

Hall in Tirol, Austria

Häckel

Kirchdorf, Austria

Prieler

Neufeld A.d. Leitha, Austria

Maurer

Salzburg, Austria

Sommer

Vienna, Austria

Angermayr

Wels, Austria

Site 27

Boskovice, Czechia

Site 19

Brno, Czechia

Site 22

Chomutov, Czechia

...and 49 more locations

Time frame: one month after third vaccination and pre dose fourth (booster) vaccination

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.

Time frame: One month post vaccination and pe-booster (fourth) dose vaccination

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.

Time frame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination

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.

Time frame: 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.

Time frame: 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).

Time frame: One month after the fourth (booster) dose.

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.

Time frame: One month after the first dose and one month after the second dose.

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).

Time frame: One month after the fourth (booster) dose.

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.

Time frame: From day 1 to day 7 after each rMenB+OMV NZ vaccination.

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).

Time frame: From day 1 to day 7 after each rMenB+MV NZ vaccination.

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.

Time frame: From day 1 to day 7 after MMRV vaccination.

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.

Time frame: From day 8 to day 28 after MMRV vaccination.