Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00661713

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 II Phase III

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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, Month 6 and Month 7 [ 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 of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by geometric mean titers (GMTs), geometric mean ratios (GMRs) computed for each visit and meningococcal B strain. [ 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 ]

Estimated Enrollment:	1625
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0 and 6 and placebo at study months 1 and 2.
2: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study month 0 and placebo at study months 1, 2 and 6.
3: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0, 1 and 6 and placebo at study month 2.
4: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0 and 1 and placebo at study months 2 and 6.
5: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0, 2 and 6 and placebo at study month 1.
6: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0 and 2 and placebo at study months 1 and 6.
7: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of rMenB+OMV NZ at study months 0, 1 and 2 and placebo at study month 6.
8: Experimental	Biological: Serogroup B meningococcal Vaccine One dose of placebo at study months 0, 1, 2 and one dose of rMenB+OMV NZ 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

Contacts

Contact: Novartis Vaccines Drug Information Services

+1 800 244 7668

Locations

Chile
Complejo Educacional Eduardo Cuevas Valdés	Recruiting
Lo Barnechea, Chile

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	V72P10
Study First Received:	April 16, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00661713
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

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Neisseria meningitidis
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 15, 2009