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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 6, 2011
Last updated: December 3, 2012
Last verified: December 2012

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

Condition Intervention Phase
Invasive Meningococcal Disease
Biological: Meningococcal ABCWY vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of subjects with hSBA seroresponse at 30 days after last vaccination [ Time Frame: 2- 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic reactions and adverse events [ Time Frame: From first vaccination up to 6 months after last vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 484
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
Active Comparator: Arm 2
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
Placebo Comparator: Arm 3
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
Placebo Comparator: Arm 4
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm


Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adolescents aged 10 to 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01272180

United States, Alabama
Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
United States, California
Madera Family Medical Group,1111 West 4th Street
Madera, California, United States, 93637
Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301
Paramount, California, United States, 90723
United States, Kentucky
Kentucky Pediatric/Adult Research, 201 south 5th street
Bardstown, Kentucky, United States, 40004
Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2
Louisville, Kentucky, United States, 40291
United States, Ohio
Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C
Huber Heights, Ohio, United States, 45424
Ohio Pediatric Research Association, 1775 Delco Park Drive
Kettering, Ohio, United States, 45420
United States, Tennessee
Focus Research Group,201 Signature Place
Lebanon, Tennessee, United States, 37087
Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41
Izabelin (Warszawa), Poland, 05-080
NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15
Kraków, Poland, 31-422
NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12
Kraków, Poland, 31-223
Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80
Warszawa, Poland, 01-809
Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44
Wrocław, Poland, 50-354
Sponsors and Collaborators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis Identifier: NCT01272180     History of Changes
Other Study ID Numbers: V102_03, 2010-023523-23
Study First Received: January 6, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration
Polish: Ministry of Health

Keywords provided by Novartis:

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections processed this record on September 18, 2014