Phase 2
Completed N=604
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Infections, Meningococcal
Source: ClinicalTrials.gov NCT02946385 ↗
Enrolled (actual)
604
Serious AEs
0.5%
Results posted
Aug 2019
Primary outcomePrimary: Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects — 18; 16; 25; 17 Percentage of subjects
Summary
The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last meningococcal vaccination in the parent study V102\_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at similar age at enrolment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects |
18; 16; 25; 17; 5; 71 | — |
| PRIMARY hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects |
2.05; 2; 2.55; 2.02; 1.21; 13 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 |
87; 85; 95; 29; 100; 100 | — |
| SECONDARY Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 |
54; 49; 65; 8; 91; 95 | — |
| SECONDARY hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 |
32; 30; 61; 3.12; 580; 529 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups |
18; 17; 26; 6; 64; 82 | — |
| SECONDARY Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups |
26; 36; 50; 30; 55; 49 | — |
| SECONDARY hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups |
2.08; 2.04; 2.62; 1.28; 13; 21 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1 |
94; 28; 100; 74; 87; 27 | — |
| SECONDARY Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1 |
67; 15; 97; 19; 40; 16 | — |
| SECONDARY hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1 |
50; 3.48; 820; 18; 27; 3.14 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups |
82; 36; 98; 88; 100; 98 | — |
| SECONDARY Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups |
34; 22; 66; 31; 78; 69 | — |
| SECONDARY hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups |
2.04; 1.18; 14; 12; 49; 16 | — |
| SECONDARY Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any Unsolicited AEs Within 30 Minutes After Vaccination |
— | — |
| SECONDARY Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. |
22; 10; 14; 22; 23; 20 | — |
| SECONDARY Number of Subjects With Unsolicited AEs, 30 Days After Any Vaccination |
27; 12; 10; 26; 40; 36 | — |
| SECONDARY Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal |
18; 7; 8; 20; 24; 21 | — |
Eligibility Criteria
Inclusion Criteria
Follow-on Participants
- Subjects from Finland and Poland previously enrolled in study V102\_15 (NCT02212457) who have received all planned meningococcal vaccinations in the study
- Who have not received any additional meningococcal vaccination since the last meningococcal vaccination administered in the parent trial.
- Who have given written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Naive Group
- Male and female individuals of similar age (approximately 12-20 years) to follow-on subjects from V102\_15 (NCT02212457) trial.
- Who have not received any meningococcal vaccination since birth
- Individuals who have given their written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria
Follow-on Participants:
- Follow-on individuals not eligible to be enrolled in the study are those with:
- History of any meningococcal vaccine administration since last meningococcal vaccination administered in V102\_15 (NCT02212457) parent study.
- Current or previous, confirmed or suspected disease caused by N. meningitidis, since termination from parent study.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
- If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
- Pregnancy or breast-feeding
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
- Progressive, unstable or uncontrolled clinical conditions.
- Any confirmed or suspected condition with impaired/altered function of immune system.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/day. Inhaled, intranasal and topical steroids are allowed).
- Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the 3 months prior to study enrolment.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after vaccination in the study.
- Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
- Who have received systemic antibiotic treatment within 3 days prior to any blood draw
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Naive Individuals
- Naive individuals not eligible to be enrolled in the study are those with:
- History of any meningococcal vaccine administration since birth.
- C
Data sourced from ClinicalTrials.gov (NCT02946385). 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.