Phase 2
Completed N=189
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Source: ClinicalTrials.gov NCT02285777 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series. — 21.1; 73.7 Percentages of subjects — p=0.0001
Summary
This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102\_16 study will be invited at the time of their last study visit to participate in this extension study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series. |
21.1; 73.7 | 0.0001 sig |
| SECONDARY Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series. |
33.9; 69.9 | 0.0001 sig |
| SECONDARY Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series. |
36.9; 75.8; 60.3; 79.6 | 0.0001 sig |
| SECONDARY Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series |
56.97; 22.94; 77.78; 21.91; 62.37; 22.49 | — |
| SECONDARY Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series |
98; 12; 72; 12; 67; 2 | — |
| SECONDARY HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains |
23.12; 1.1; 3.93; 1.18; 12.26; 1.74 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series. |
63; 12; 90; 1; 79; 1 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series |
99; 32; 23; 12; 36; 3 | — |
| SECONDARY Percentages of Subjects With a Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series. |
87; 12; 38; 1; 67; 0 | — |
| SECONDARY Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series. |
79; 5; 23; 1; 41; 0 | — |
| SECONDARY Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series. |
63; 3; 12; 0; 23; 0 | — |
| SECONDARY HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. |
127.92; 3.37; 36.5; 2.73; 521.64; 18.34 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series |
98; 24; 100; 73; 99; 60 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series |
81; 18; 100; 69; 89; 51 | — |
| SECONDARY Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series. |
88; 2; 87; 2; 83; 5 | — |
| SECONDARY Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series. |
69; 0; 60; 1; 67; 0 | — |
| SECONDARY Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series. |
53; 0; 49; 1; 49; 0 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series |
100; 38; 100; 37; 100; 25 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series |
99; 35; 99; 33; 98; 21 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series |
98; 30; 98; 26; 98; 22 | — |
| SECONDARY Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series |
86; 25; 84; 23; 72; 18 | — |
| SECONDARY Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) |
62; 25; 60; 15; 27; 15 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited AEs |
14; 11 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal. |
0; 0; 14; 20; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
Exclusion Criteria
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
- History of any meningococcal vaccine administration other than vaccination given in the parent V102\_16 protocol.
Data sourced from ClinicalTrials.gov (NCT02285777). 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.