Phase 2 N=305 Randomized Quadruple-blind Prevention

Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Meningococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02140762 ↗

Enrolled (actual)

305

Serious AEs

0.3%

Results posted

Jun 2018

Primary outcome: Primary: Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination. — 25.17; 76.19 Percentages of subjects — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MenABCWY (Biological); Placebo (Other); MenACWY (Biological)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.	25.17; 76.19	<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 Second Vaccination.	42.91; 76.67	< 0.0001 sig
SECONDARY Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination	47.7; 88.28	<0.0001 sig
SECONDARY Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.	70.89; 88.53	< 0.0001 sig
SECONDARY Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	19.82; 19.73; 56.38; 22.66; 9.19; 9.52	—
SECONDARY Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	19.82; 19.73; 56.38; 22.66; 9.19; 9.52	—
SECONDARY Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	67; 1; 24; 0; 96; 12	—
SECONDARY Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	14; 5; 3; 2; 83; 20	—
SECONDARY hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	6.03; 1.04; 13.4; 1.08; 5.05; 1.65	—
SECONDARY HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	1.75; 1.06; 3.04; 1.12; 1.77; 1.56	—
SECONDARY hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	77.02; 22.08; 235.88; 38.61; 157.72; 37.51	—
SECONDARY HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	12.91; 5.56; 117.18; 25.64; 91.22; 42.97	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	30; 32; 99; 30; 3; 7	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	2; 1; 93; 63; 32; 43	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	95; 30; 26; 1; 10; 10	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	48; 32; 98; 78; 77; 58	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	14; 2; 9; 1; 3; 0	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	72; 43; 65; 38; 36; 29	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	60; 2; 45; 2; 17; 0	—
SECONDARY Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	98; 72; 96; 69; 90; 57	—
SECONDARY Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	92; 6; 13; 2; 55; 0	—
SECONDARY Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	91; 2; 8; 0; 34; 0	—
SECONDARY Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	87; 1; 2; 0; 22; 0	—
SECONDARY Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	81; 48; 98; 66; 74; 25	—
SECONDARY Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	13; 14; 88; 48; 32; 22	—
SECONDARY Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	45; 26; 95; 54; 50; 15	—
SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	129; 92; 128; 65; 70; 66	—
SECONDARY Number of Subjects Reporting Unsolicited AEs.	28; 28; 7; 3; 37; 44	—

Summary

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Eligibility Criteria

Inclusion Criteria

Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria

Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02140762). 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.