Phase 2
Completed N=1,063
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Infections, Meningococcal
Source: ClinicalTrials.gov NCT02212457 ↗
Enrolled (actual)
1,063
Serious AEs
3.3%
Results posted
Jul 2017
Primary outcomePrimary: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. — 1.28; 1.31; 11.64; 15.78 Titers
Summary
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. |
1.28; 1.31; 11.64; 15.78; 2.12; 2.16 | — |
| SECONDARY hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. |
1.21; 1.12; 12.17; 27.09; 2.36; 2.05 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. |
6; 2; 63; 74; 5; 2 | — |
| SECONDARY hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. |
12.32; 6.33; 13.64; 15.87; 12.72; 9.19 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. |
7; 6; 88; 61; 7; 5 | — |
| SECONDARY hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. |
13.62; 17.13; 27.82; 29.27; 17.43; 20.92 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. |
5; 2; 64; 74; 5; 2 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. |
63; 44; 64; 73; 70; 62 | — |
| SECONDARY hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. |
1.22; 1.22; 1.21; 1.13; 1.12; 1.06 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. |
7; 6; 6; 5; 4; 2 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. |
7; 5; 6; 4; 7; 2 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. |
21; 18; 17; 14; 21; 19 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. |
23; 29; 29; 28; 25; 27 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. |
6; 3; 5; 2; 3; 1 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. |
43; 45; 48; 41; 48; 41 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. |
30; 26; 29; 20; 29; 22 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. |
15; 10; 13; 6; 13; 7 | — |
| SECONDARY Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. |
18; 13; 28; 9; 21; 12 | — |
| SECONDARY The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. |
26.52; 38.01; 98.62; 38.05; 57.12; 27.86 | — |
| SECONDARY Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. |
3; 0; 1; 2; 0; 1 | — |
| SECONDARY Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination. |
146; 148; 93; 76; 97; 104 | — |
| SECONDARY Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. |
225; 228; 153; 131; 151; 157 | — |
| SECONDARY Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal |
9; 3; 8; 7; 2; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
- Female subjects of childbearing potential must have a negative urine preganancy test.
Exclusion Criteria
- Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
- Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
Data sourced from ClinicalTrials.gov (NCT02212457). 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.