Phase 3
Completed N=531
Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
Infections, Meningococcal
Source: ClinicalTrials.gov NCT02446743 ↗
Enrolled (actual)
531
Serious AEs
0.2%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 — 84; 84; 84; 7 Percentage of subjects
◆ Published Evidence
Established
54citations · ~8 / year
Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine.
Summary
The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72\_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ
Linked Publications
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Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 |
84; 84; 84; 7; 24; 17 | — |
| PRIMARY Percentage of Subjects With hSBA≥1:5 |
26; 41; 33; 5; 11; 9 | — |
| PRIMARY Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 |
1; 23; 99; 100; 34; 73 | — |
| PRIMARY Percentage of Subjects With hSBA≥1:8 |
22; 35; 28; 1; 9; 6 | — |
| PRIMARY Percentage of Subjects With hSBA≥1:16 |
12; 28; 20; 0; 7; 4 | — |
| PRIMARY hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. |
99; 197; 124; 2.43; 4.51; 3.05 | — |
| PRIMARY Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. |
0.026; 0.023; 0.025; 0.13; 0.052; 0.098 | — |
| PRIMARY Number of Subjects With Solicited Local and Systemic AEs. |
263; 251; 258; 247; 258; 247 | — |
| PRIMARY Number of Subjects With Any Unsolicited Adverse Events (AEs). |
87; 131; 87; 96; 73 | — |
| PRIMARY Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. |
0; 1; 17; 34; 0; 1 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ. |
100; 100; 100; 87; 84; 85 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ. |
98; 100; 99; 80; 79; 79 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ |
98; 100; 99; 67; 74; 72 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ |
98; 99; 99; 49; 65; 58 | — |
| SECONDARY hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. |
2.45; 4.65; 3.10; 1.13; 1.53; 1.19 | — |
| SECONDARY Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. |
65; 58; 61; 12; 16; 14 | — |
| SECONDARY Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination |
95; 98; 96; 66; 72; 70 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ |
78; 80; 79; 82; 88; 85 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ |
28; 46; 36; 74; 85; 80 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ |
22; 39; 30; 70; 80; 75 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ |
13; 29; 21; 40; 60; 50 | — |
| SECONDARY hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. |
2.41; 4.61; 2.99; 14; 27; 17 | — |
| SECONDARY Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. |
65; 62; 66; 4.21; 2.37; 3.27 | — |
| SECONDARY Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination |
2; 2; 2; 6; 2; 4 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ |
100; 97; 98; 82; 79; 80 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ |
99; 99; 99; 90; 96; 93 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. |
99; 97; 98; 100; 97; 98 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. |
91; 91; 91; 100; 96; 98 | — |
| SECONDARY hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. |
1.08; 1.56; 1.32; 57; 64; 61 | — |
| SECONDARY Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 |
52; 41; 46; 204; 123; 156 | — |
| SECONDARY Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination |
97; 94; 95; 100; 94; 97 | — |
Eligibility Criteria
Inclusion Criteria
- Inclusion Criterion for follow-on subjects:
- Individuals who participated to Study V72\_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
Inclusion Criterion for naïve subjects:
- Individuals of 15 through 21 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72\_41.
- 17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
Inclusion Criteria for all subjects:
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up.
- Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .
Exclusion Criteria for all subjects
Exclusion Criterion for follow-on subjects:
- Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
Exclusion Criterion for naïve subjects:
- Received any other Meningococcal group B vaccines prior to enrolment in this study.
Exclusion Criteria for all subjects:
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study.
- Abnormal function of the immune system.
- Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (according to the subject's age).
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject's age).
- Study personnel as an immediate family or household member.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
- Positive results at the urine pregnancy test performed before study vaccination.
Data sourced from ClinicalTrials.gov (NCT02446743) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.