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

Meningococcal Disease Clinical Trial

Official title:

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140762
• Other study ID #: V102_16
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• MenABCWY
Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.

Other:
• Placebo
0.5 mL saline solution (IM)

Biological:
• MenACWY
Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.

Locations

Country	Name	City	State
United States	Senders Pediatrics	Cleveland	Ohio
United States	Accelovance, Inc	Huntsville	Alabama
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Accelovance, Inc	Melbourne	Florida
United States	Heartland Research Associates LLC	Newton	Kansas
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10. — View Citation

Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.; Least Square (LS)-mean computed from the generalized linear model.	One month after the second vaccination (month 3)
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.	The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.; Least Square (LS)-mean computed from the generalized linear model.	Four months after the second vaccination (month 6)
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	The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.; Least Square (LS)-mean computed from the generalized linear model.	One month after the second vaccination (month 3)
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.	The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.; Least Square (LS)-mean computed from the generalized linear model.	Four months after the second vaccination (month 6)
Secondary	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.	Baseline, one month after second vaccination (month 3)
Secondary	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.	Baseline, four months after second vaccination (month 6)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA >= 1:4 and enc-hSBA titer >= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.	One month after the second vaccination (month 3)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA = 1:4 and enc-hSBA titer = 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.	Four months after the second vaccination (month 6)
Secondary	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.	One month after the second vaccination (month 3)
Secondary	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.	Four months after the second vaccination (month 6)
Secondary	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.	One month after the second vaccination (month 3)
Secondary	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.	Four months after the second vaccination (month 6)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains = LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.	At baseline(day 1) and One month after the second vaccination (month 3)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.	At Baseline and One month after the second vaccination (month 3)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains = LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively	Four months after the second vaccination (month 6)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.	Four months after the second vaccination (month 6)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the 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, is reported.	Four months after the second vaccination (month 6)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = 8, = 16, = 32, = 64, = 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.	Four months after the second vaccination (month 6)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the 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, is reported.	One month after the second vaccination (month 3)
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	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = 8, = 16, = 32, = 64, = 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.	One month after the second vaccination (month 3)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the 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 2-dose vaccination series.The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.; The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.; The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series.; The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 (one and four months after 2 doses of vaccination)
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.	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.; The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Secondary	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.	From day 1 (6 hours) until day 7 after any vaccination
Secondary	Number of Subjects Reporting Unsolicited AEs.	Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).	From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.