Clinical trial NCT01272180: Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Invasive Meningococcal Disease
Keywords: Safety
Immunogenicity
Vaccine
Meningococcal
Seroresponse
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 484
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
timeFrame: One month after the second vaccination (Day 91)
measure: Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.
timeFrame: One month after the second vaccination (Day 91)
Secondary outcomes:
measure: 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.
timeFrame: Day 1 and one month after second vaccination (Day 91)
measure: The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
timeFrame: Day 1 and one month after the second vaccination (Day 91)
measure: 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.
timeFrame: Day 1 and one month after the second vaccination (Day 91)
measure: 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.
timeFrame: One month after the second vaccination (Day 91)
measure: The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
timeFrame: Day 1 and one month after the second vaccination (Day 91)
measure: The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
timeFrame: One month after the second vaccination/prevaccination (Day 91/day 1)
measure: The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.
timeFrame: Day 1 through day 7 after any vaccination
measure: The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.
timeFrame: Throughout the study ( Day 1 to Day 241)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615
state: Alabama
city: Madera
country: United States
facility: Madera Family Medical Group,1111 West 4th Street
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301
state: California
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research, 201 south 5th street
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2
state: Kentucky
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C
state: Ohio
city: Kettering
country: United States
facility: Ohio Pediatric Research Association, 1775 Delco Park Drive
state: Ohio
city: Lebanon
country: United States
facility: Focus Research Group,201 Signature Place
state: Tennessee
city: Izabelin (Warszawa)
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41
city: Kraków
country: Poland
facility: NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12
city: Kraków
country: Poland
facility: NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15
city: Warszawa
country: Poland
facility: Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80
city: Wrocław
country: Poland
facility: Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Szenborn L, Block SL, Jackowska T, Konior R, D'Agostino D, Smolenov I, Toneatto D, Welsch JA. Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study. Pediatr Infect Dis J. 2018 May;37(5):475-482. doi: 10.1097/INF.0000000000001896.