A Phase 3 interventional study of Serogroup B meningococcal vaccine in Meningococcal Disease and Meningococcal Meningitis, sponsored by Novartis. Completed at 13 sites in 2 countries. Open to participants aged 11 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-20.
Sponsored by Novartis · Phase 3, Interventional, and Prevention
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 344 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MenB vaccine Lot 1: 2 doses administered 1 month apart
Biological: Serogroup B meningococcal vaccine
MenB vaccine Lot 2: 2 doses administered 1 month apart
Biological: Serogroup B meningococcal vaccine
All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
Time frame: One month after the second vaccination (day 61)
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Time frame: One month after the second vaccination (day 61)
Percentage of Subjects in Each Lot With hSBA ≥ 1:5
The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group
Time frame: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.
The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
Time frame: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
Time frame: One month after the second vaccination (day 61)
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.
The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Time frame: Two weeks after the second vaccination (day 45)
GMR of ELISA GMCs Against Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
Time frame: Two weeks after the second vaccination (day 45)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
Time frame: From day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs
Number of subjects reporting any Unsolicited AEs after any vaccination.
Time frame: From day 1 to day 7 after any vaccination.
Number of Subjects Reporting SAEs and AE Leading to Withdrawal
Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
Time frame: Throughout the study period.
Actual start date of recruiting was 30 August 2011. Subjects were recruited from 7 centres in Canada and 6 centres in Australia.
| Milestone | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| Started | 170 | 174 |
| Completed | 168 | 170 |
| Not completed | 2 | 4 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 3 |
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
| Titers | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| H44/76 strain | 111 (96 to 129) | 111 (96 to 128) |
| NZ98/254 strain | 9.27 (7.44 to 12) | 11 (9.22 to 14) |
| 5/99 strain (N=152) | 183 (160 to 209) | 199 (174 to 227) |
The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group
| Percentage of subjects | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| H44/76 strain (N=151) | 99 (96 to 100) | 99 (96 to 100) |
| NZ98/254 strain (N=151) | 70 (62 to 77) | 79 (72 to 86) |
| 5/99 strain | 100 (98 to 100) | 100 (98 to 100) |
The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
| Ratio of GMTs | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| H44/76 strain (N=151) | 104 (89 to 121) | 107 (92 to 124) |
| NZ98/254 strain (N=151) | 8.63 (6.99 to 11) | 11 (8.99 to 14) |
| 5/99 | 156 (133 to 183) | 167 (143 to 195) |
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
| Ratio of GMTs | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 | 122 (103 to 143) | 153 (131 to 179) |
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
| Titers | 4CMenB_Rosia | MenB Lot 2 |
|---|---|---|
| H44/76 strain | 187 (152 to 229) | 171 (139 to 210) |
| NZ98/254 strain | 14 (10 to 18) | 20 (15 to 27) |
| 5/99 strain | 254 (206 to 314) | 339 (273 to 420) |
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination.
| Ratio of GMTs | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| H44/76 strain | 174 (138 to 219) | 157 (124 to 199) |
| NZ98/254 | 13 (9.87 to 17) | 20 (15 to 26) |
| 5/99 strain | 214 (161 to 284) | 243 (183 to 325) |
The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
| Percentage of subjects | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| H44/76 strain | 100 (95 to 100) | 100 (95 to 100) |
| NZ98/254 strain | 84 (74 to 92) | 96 (88 to 99) |
| 5/99 strain | 100 (95 to 100) | 100 (95 to 100) |
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
| IU/ml | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. | 3742 (2994 to 4676) | 4798 (3825 to 6019) |
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
| IU/ml | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 | 2729 (2338 to 3186) | 3291 (2829 to 3828) |
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
| Ratio of GMTs | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| GMR of ELISA GMCs Against Antigen 287-953 at Day 45. | 166 (130 to 213) | 217 (169 to 279) |
Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
| Number of subjects | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| Any local | 163 | 170 |
| Induration | 65 | 75 |
| Pain | 162 | 170 |
| Erythema | 111 | 111 |
| Swelling | 80 | 74 |
| Any systemic | 136 | 150 |
| Nausea | 49 | 56 |
| Fatigue | 75 | 85 |
| Myalgia | 99 | 118 |
| Arthralgia | 28 | 44 |
| Headache | 75 | 89 |
| Fever (>= 38C) | 8 | 5 |
| Rash | 11 | 16 |
| Any other | 87 | 96 |
| Use of analgesics | 82 | 92 |
Number of subjects reporting any Unsolicited AEs after any vaccination.
| Number of subjects | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| Number of Subjects Reporting Unsolicited AEs | 56 | 55 |
Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
| Number of subjects | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| Serious Adverse Events | 0 | 0 |
| Adverse Events | 0 | 1 |
Collected over SAEs were collected from day 1 through study termination, other AEs were collected from day 1 to day 7 after vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4CMenB_Rosia | — | 0/169 (0%) | 165/169 (97.6%) |
| 4CMenB_Siena | — | 0/173 (0%) | 171/173 (98.8%) |
| Event | 4CMenB_Rosia | 4CMenB_Siena |
|---|---|---|
| injection site painGeneral disorders | 162/169 | 170/173 |
| myalgiaMusculoskeletal and connective tissue disorders | 99/169 | 118/173 |
| injection site erythemaGeneral disorders | 111/169 | 111/173 |
| HeadacheNervous system disorders | 75/169 | 89/173 |
| FatigueGeneral disorders | 75/169 | 85/173 |
| injection site swellingInvestigations | 80/169 | 74/173 |
| injection site indurationGeneral disorders | 65/169 | 75/173 |
| nauseaGastrointestinal disorders | 49/169 | 56/173 |
| arthralgiaMusculoskeletal and connective tissue disorders | 28/169 | 45/173 |
| rashSkin and subcutaneous tissue disorders | 11/169 | 16/173 |
adolescents aged 11-17 years
| Age, Continuous(years) | 4CMenB_Rosia | 4CMenB_Siena | Total |
|---|---|---|---|
| Mean | 13.6 ± 1.9 | 13.8 ± 1.8 | 13.7 ± 1.9 |
| Sex: Female, Male(Participants) | 4CMenB_Rosia | 4CMenB_Siena | Total |
|---|---|---|---|
| Female | 72 | 82 | 154 |
| Male | 98 | 92 | 190 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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