Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

This study has been completed.
Sponsor:
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

February 27, 2006
January 3, 2012
February 2006
April 2007   (final data collection date for primary outcome measure)
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 ]
Safety, tolerability and immunogenicity of the two vaccines in healthy adolescents, 1 month after completion of immunization schedule.
Complete list of historical versions of study NCT00297817 on ClinicalTrials.gov Archive Site
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 ]
Safety, tolerability and immunogenicity of the two vaccines in healthy adolescents, 6 months after completion of immunization schedule.
Not Provided
Not Provided
 
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Meningococcal Disease
  • 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.
  • 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.
  • Experimental: Arm 1: rMenB
    Intervention: Biological: serogroup B meningococcal vaccine
  • Experimental: Arm 2: rMenB + OMV
    Intervention: Biological: serogroup B meningococcal vaccine
  • Placebo Comparator: Arm 3: Placebo
    Intervention: Biological: serogroup B meningococcal vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297817
V72P3
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines - Drug Information Services Novartis
Novartis
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP