Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00297817
First received: February 27, 2006
Last updated: January 3, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease |
Biological: serogroup B meningococcal vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age |
Resource links provided by NLM:
MedlinePlus related topics:
Meningococcal Infections
Drug Information available for:
Meningococcal Vaccines
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents [ Time Frame: 1 month after completion of immunization schedule ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents [ Time Frame: 6 months after completion of immunization schedule ] [ Designated as safety issue: Yes ]
| Enrollment: | 203 |
| Study Start Date: | February 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: rMenB |
Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
|
| Experimental: Arm 2: rMenB + OMV |
Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
|
| Placebo Comparator: Arm 3: Placebo |
Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
|
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
Exclusion Criteria:
- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297817
Locations
| United States, California | |
| Encinitas, California, United States, 92024 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44118 | |
| United States, Texas | |
| Galveston, Texas, United States, 77555 | |
| United States, Utah | |
| Layton, Utah, United States, 84123 | |
| Salt Lake City, Utah, United States, 84121 | |
| United States, Washington | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines - Drug Information Services | Novartis |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00297817 History of Changes |
| Other Study ID Numbers: | V72P3 |
| Study First Received: | February 27, 2006 |
| Last Updated: | January 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Meningococcal Disease; Meningococcal Meningitis; Vaccine |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 17, 2013