Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01272180
First received: January 6, 2011
Last updated: December 3, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
RMENB (+OMV) + MENACWY
|
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
|
|
Active Comparator: Arm 2
RMENB (+1/4 OMV) + MENACWY
|
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
|
|
Placebo Comparator: Arm 3
RMENB (+OMV)
|
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
|
|
Placebo Comparator: Arm 4
(VACCINATION 1) / MENVEO (VACCINATION 2)
|
Biological: Meningococcal ABCWY vaccine
Two shots of two different combination vaccine formulations versus control arm
|
Eligibility| Ages Eligible for Study: | 10 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272180
Locations
| 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 | |
| Poland | |
| 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
Novartis
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov 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:
|
Safety Immunogenicity Vaccine Meningococcal Seroresponse |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013