Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00661713
First received: April 16, 2008
Last updated: October 24, 2011
Last verified: October 2011
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Purpose
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease |
Biological: Serogroup B meningococcal Vaccine |
Phase 2 Phase 3 |
| 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 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules |
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:
- Immunogenicity of one, two or three doses of Novartis Meningococcal B vaccine as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 at baseline, Month 1, Month 2, Month 3. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Safety of 1, 2 or 3 doses of Novartis MenB Vaccine assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccine injection and evaluation of occurrence of AE and SAE during the duration of all the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunogenicity at month 6 and 7 as measured by geometric mean titers (GMTs), geometric mean ratios (GMRs) computed for each visit and meningococcal B strain. For Group 5 unadjusted geometric mean titers (GMTs) will be computed up to Month 6. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by: % of subjects with a SBA titer ≥ 1:8 measured at baseline, 1, 2, 3, 6 and Month 7; % of subjects with at least a fourfold rise in SBA titer over the pre-vaccination titer. [ Time Frame: 7 months ] [ Designated as safety issue: No ]Safety of an additional dose of Novartis MenB vaccine, given at month 6 assessed by frequency of solicited local and systemic reactions collected for 7 days after vaccine injection and evaluation of occurrence of AE and SAE.
| Enrollment: | 1627 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0 and 6 and placebo at study months 1 and 2.
|
| Experimental: 2 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study month 0 and placebo at study months 1, 2 and 6. |
| Experimental: 3 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0, 1 and 6 and placebo at study month 2.
|
| Experimental: 4 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0 and 1 and placebo at study months 2 and 6.
|
| Experimental: 5 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0, 2 and 6 and placebo at study month 1.
|
| Experimental: 6 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0 and 2 and placebo at study months 1 and 6.
|
| Experimental: 7 |
Biological: Serogroup B meningococcal Vaccine
One dose of rMenB at study months 0, 1 and 2 and placebo at study month 6.
|
| Experimental: 8 |
Biological: Serogroup B meningococcal Vaccine
One dose of placebo at study months 0, 1, 2 and one dose of rMenB at study month 6.
|
Eligibility| Ages Eligible for Study: | 11 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
Exclusion Criteria:
- History of any meningococcal B vaccine administration
- Current or previous, confirmed or suspected disease caused by N. meningitidis
- Pregnancy or nursing (breastfeeding) mothers
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures,
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Any serious chronic or progressive disease
- Known or suspected impairment or alteration of the immune system
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661713
Locations
| Chile | |
| Colegio Antonio Hermida Fabres | |
| Av. Coronel Alejandro Sepúlveda n° 6801, Chile | |
| Liceo José Victorino Lastarria | |
| Av. Miguel Claro n° 32. Phone/ Fax: 56 2 2353835, Chile | |
| Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio | |
| Av. Prof Zañartu 1085, Chile | |
| Liceo Carmela Carvajal de Prat | |
| Avda. Italia 980, Chile | |
| Colegio Parroquial Santa Rosa de Lo Barnechea | |
| Avda. Raúl Labbé Nº 13.799, Chile | |
| Centro Educacional Eduardo de la Barra | |
| Calle A, n° 6301, Chile | |
| Facultad de Medicina. Universidad de Valparaíso. | |
| Hontaneda # 2653. Valparaíso, Chile | |
| Complejo Educacional Eduardo Cuevas Valdés | |
| Lo Barnechea, Chile | |
| Complejo Educacional Eduardo Cuevas Valdés | |
| Álvarez Nº 14.053, Chile | |
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00661713 History of Changes |
| Other Study ID Numbers: | V72P10 |
| Study First Received: | April 16, 2008 |
| Last Updated: | October 24, 2011 |
| Health Authority: | United States: Food and Drug Administration Chile: División de Prevención y Control de Enfermedades |
Keywords provided by Novartis:
|
Meningococcal disease Neisseria meningitidis serogroup B prevention vaccination adolescents |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013