Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Invasive Meningococcal Disease Clinical Trial

Official title:

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272180
• Other study ID #: V102_03
• Secondary ID: 2010-023523-23
• Status: Completed
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: September 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.

Exclusion Criteria:

• History of any meningococcal vaccine administration;

• Current or previous, confirmed or suspected disease caused by N. meningitidis;

• Pregnant or nursing (breastfeeding) mothers;

• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;

• Any serious, chronic, or progressive disease;

• Known or suspected impairment/alteration of the immune system;

• Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;

• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.

Related Conditions & MeSH terms

• Invasive Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.
• Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
• Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
• Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.

Locations

Country	Name	City	State
Poland	Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kosciuszki 41	Izabelin (Warszawa)
Poland	NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12	Kraków
Poland	NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15	Kraków
Poland	Klinika Pediatrii Centrum Medycznego Ksztalcenia PodyplomowegoSzpital Bielanski, ul. Ceglowska 80	Warszawa
Poland	Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44	Wroclaw
United States	Kentucky Pediatric/Adult Research, 201 south 5th street	Bardstown	Kentucky
United States	Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615	Birmingham	Alabama
United States	Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C	Huber Heights	Ohio
United States	Ohio Pediatric Research Association, 1775 Delco Park Drive	Kettering	Ohio
United States	Focus Research Group,201 Signature Place	Lebanon	Tennessee
United States	Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2	Louisville	Kentucky
United States	Madera Family Medical Group,1111 West 4th Street	Madera	California
United States	Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301	Paramount	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.	Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.; Seroresponse is defined as: For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer = 1:8; For subjects with a pre-vaccination hSBA titer = 1:4, an increase in hSBA titer of at least four times the prevaccination titer.; Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).	One month after the second vaccination (Day 91)
Primary	Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.	The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.	One month after the second vaccination (Day 91)
Secondary	Percentages of Subjects With hSBA Titers = 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	Percentages of subjects with hSBA titers = 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.	Day 1 and one month after second vaccination (Day 91)
Secondary	The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.	Day 1 and one month after the second vaccination (Day 91)
Secondary	Percentages of Subjects With hSBA Titers = 1:5 and = 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	The percentages of subjects with hSBA titers = 1:5 and = 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.	Day 1 and one month after the second vaccination (Day 91)
Secondary	Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.; 4-fold increase is defined as follows; for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA = 1:8, for subjects with a prevaccination hSBA = 1:2, at least a 4-fold increase.	One month after the second vaccination (Day 91)
Secondary	The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.	Day 1 and one month after the second vaccination (Day 91)
Secondary	The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.	The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.	One month after the second vaccination/prevaccination (Day 91/day 1)
Secondary	The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.	The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.	Day 1 through day 7 after any vaccination
Secondary	The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.	The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.	Throughout the study ( Day 1 to Day 241)