Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
Completed · Phase 2 · Has a placebo group
Conditions studied: Invasive Meningococcal Disease
In brief
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Key facts
- Study ID
- NCT01272180
- Run by
- Novartis Vaccines
- People needed
- 484
- Starts
- 2011-08-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2020-06-16
Who can join
Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.
You may not qualify if…
- 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.
Where it is running
- Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615 — Birmingham, Alabama, 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, United States
- Kentucky Pediatric/Adult Research, 201 south 5th street — Bardstown, Kentucky, United States
- Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2 — Louisville, Kentucky, 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
- Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41 — Izabelin (Warszawa), Poland
- NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12 — Krakow, Poland
- NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15 — Krakow, Poland
- Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80 — Warsaw, Poland
- Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44 — Wroclaw, Poland
Full record on ClinicalTrials.gov
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