A Phase 2 interventional study of Men ACWY CRM and 4CMenB in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 54 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: 4CMenB
Biological: Men ACWY CRM
A single dose of a 0.5 mL injectable solution
All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Time frame: One month after vaccinations
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
Time frame: One month after vaccinations
Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
Time frame: One month after vaccinations
Participants were enrolled at one site in Italy and one site in Germany.
| Milestone | 4CMenB |
|---|---|
| Started | 54 |
| Completed | 48 |
| Not completed | 6 |
| Withdrew: Adverse events or death | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Protocol violation | 1 |
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
| titer | 4CMenB (44/76-SL) | 4CMenB (5/99) | 4CMen B (NZ98/254) |
|---|---|---|---|
| Baseline titer | 2.5 (1.7 to 3.5) | 2.3 (1.6 to 3.2) | 1.8 (1.3 to 2.6) |
| Post dose 1 titer (N=25) | 33 (15 to 72) | 29 (14 to 60) | 23 (11 to 49) |
| Post dose 2 titer | 93 (71 to 121) | 144 (108 to 193) | 32 (21 to 48) |
| Before dose 3 titer(N=24) | 26 (15 to 47) | 37 (26 to 53) | 9.4 (4.1 to 21) |
| Post dose 3 titer (N=39) | 95 (68 to 131) | 269 (205 to 354) | 30 (18 to 50) |
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
| percentage | 4CMenB (44/76-SL) | 4CMenB (5/99) | 4CMen B (NZ98/254) |
|---|---|---|---|
| titer ≥4 (Baseline) | 37 (23 to 52) | 37 (23 to 52) | 22 (11 to 36) |
| titer ≥4 (Post dose 1) N=25 | 84 (64 to 95) | 88 (69 to 97) | 80 (59 to 93) |
| titer ≥4 (Post dose 2) | 100 (92 to 100) | 100 (92 to 100) | 91 (79 to 98) |
| titer ≥4 (Before dose 3) N=24 | 96 (79 to 100) | 100 (86 to 100) | 67 (45 to 84) |
| titer ≥4 (Post dose 3) N=39 | 97 (87 to 100) | 100 (91 to 100) | 92 (79 to 98) |
| titer ≥8 (Baseline) | 26 (14 to 41) | 15 (6 to 29) | 15 (6 to 29) |
| titer ≥8 (Post dose 1) N=25 | 80 (59 to 93) | 76 (55 to 91) | 72 (51 to 88) |
| titer ≥8 (Post dose 2) | 100 (92 to 100) | 100 (92 to 100) | 83 (69 to 92) |
| titer ≥8 (Before dose 3) N=24 | 75 (53 to 90) | 100 (86 to 100) | 54 (33 to 74) |
| titer ≥8 (Post dose 3) N=39 | 97 (87 to 100) | 100 (91 to 100) | 77 (61 to 89) |
| ≥4 fold increase (Post dose 1) N=25 | 80 (59 to 93) | 64 (43 to 82) | 68 (46 to 85) |
| ≥4 fold increase (Post dose 2) | 100 (92 to 100) | 100 (92 to 100) | 78 (64 to 89) |
| ≥4 fold increase (Before dose 3) N=24 | 71 (49 to 87) | 75 (53 to 90) | 46 (26 to 67) |
| ≥4 fold increase (Post dose 3) N=39 | 92 (79 to 98) | 100 (91 to 100) | 69 (52 to 83) |
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
| titer | MenACWY-CRM (A) | MenACWY-CRM (C) | MenACWY-CRM (W-135) | MenACWY-CRM (Y) |
|---|---|---|---|---|
| Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | 54 (34 to 85) | 42 (27 to 66) | 90 (58 to 139) | 36 (16 to 81) |
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
| percentage | MenACWY-CRM (A) | MenACWY-CRM (C) | MenACWY-CRM (W-135) | MenACWY-CRM (Y) |
|---|---|---|---|---|
| titers ≥ 4 | 96 (78 to 100) | 100 (85 to 100) | 100 (85 to 100) | 83 (61 to 95) |
| titers ≥8 | 96 (78 to 100) | 96 (78 to 100) | 100 (85 to 100) | 83 (61 to 95) |
The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
| participants | 4CMenB (Post Dose 1) | 4CMenB (Post Dose 2) | 4CMenB (Post Dose 3) | Men ACWY-CRM (One Dose) |
|---|---|---|---|---|
| Injection pain (any) | 52 | 50 | 50 | 10 |
| Injection pain (severe) | 8 | 7 | 9 | 0 |
| Erythema (any) | 22 | 23 | 28 | 9 |
| Erythema (severe) | 0 | 0 | 0 | 0 |
| Induration (any) | 23 | 24 | 29 | 5 |
| Induration (severe) | 0 | 0 | 0 | 0 |
| Nausea (any) | 7 | 5 | 9 | 4 |
| Nausea (severe) | 2 | 0 | 0 | 0 |
| Malaise (any) | 16 | 17 | 26 | 11 |
| Malaise (severe) | 3 | 1 | 2 | 1 |
| Myalgia (any) | 15 | 19 | 24 | 5 |
| Myalgia (severe) | 3 | 3 | 7 | 1 |
| Arthralgia (any) | 10 | 12 | 20 | 6 |
| Arthralgia (severe) | 0 | 0 | 3 | 0 |
| Headache (any) | 15 | 13 | 21 | 9 |
| Headache (severe) | 2 | 0 | 0 | 1 |
| Fever (≥ 38°C) | 2 | 1 | 0 | 2 |
| Stayed home | 5 | 4 | 5 | 2 |
| Analgesic, antipyretic medicine used | 10 | 7 | 5 | 4 |
Collected over Adverse events were collected throughout the duration of the study (8 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4CMenB (1st Vaccination) | — | 0/53 (0%) | 52/53 (98.1%) |
| 4CMenB (2nd Vaccination) | — | 0/52 (0%) | 51/52 (98.1%) |
| 4CMenB (3rd Vaccination) | — | 0/50 (0%) | 50/50 (100%) |
| Men ACWY-CRM | — | 0/41 (0%) | 19/41 (46.3%) |
| Event | 4CMenB (1st Vaccination) | 4CMenB (2nd Vaccination) | 4CMenB (3rd Vaccination) | Men ACWY-CRM |
|---|---|---|---|---|
| Injection site painGeneral disorders | 52/53 | 50/52 | 50/50 | 10/41 |
| Injection site indurationGeneral disorders | 23/53 | 24/52 | 29/50 | 5/41 |
| Injection site erythemaGeneral disorders | 22/53 | 23/52 | 28/50 | 9/41 |
| MalaiseGeneral disorders | 16/53 | 17/52 | 26/50 | 11/41 |
| MyalgiaMusculoskeletal and connective tissue disorders | 15/53 | 19/52 | 24/50 | 5/41 |
| HeadacheNervous system disorders | 16/53 | 13/52 | 21/50 | 9/41 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 10/53 | 12/52 | 20/50 | 6/41 |
| NauseaGastrointestinal disorders | 7/53 | 5/52 | 9/50 | 4/41 |
| NasopharyngitisInfections and infestations | 0/53 | 3/52 | 3/50 | 1/41 |
| PyrexiaGeneral disorders | 3/53 | 1/52 | 0/50 | 2/41 |
| Age, Continuous(years) | 4CMenB |
|---|---|
| Mean | 31.8 ± 6.1 |
| Sex: Female, Male(Participants) | 4CMenB |
|---|---|
| Female | 27 |
| Male | 27 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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