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:
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
  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:


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 April 23, 2014