| August 26, 2005 |
| November 22, 2006 |
| July 2002 |
| |
| Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed |
| Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titre) at 1 month postvaccination for each MenB strain assayed |
| Complete list of historical versions of study NCT00137917 on ClinicalTrials.gov Archive Site |
- For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
- After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
- Serious adverse events [SAEs] (whole study)
|
| For each MenB strain assayed, pre & 1m post dose 2 & 3: SBA seropositivity, titer & immune response (post dose 2 only). After each vaccination: grade 3 & any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30). SAEs (whole study) |
| |
| Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs |
| A Primary Vaccination Study to Evaluate Immunogenicity, Safety & Reactogenicity of 3 Doses of GSK Biologicals/Finlay’s Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Mth or 0-1-6 Mth Schedule to Healthy Subjects Aged 12-18 Yrs |
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1). |
The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses. |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Meningitis, Meningococcal, Serogroup B |
| Biological: Meningococcal serogroup B vaccine |
| |
| Boutriau D, Poolman J, Borrow R, Findlow J, Domingo JD, Puig-Barbera J, Baldo JM, Planelles V, Jubert A, Colomer J, Gil A, Levie K, Kervyn AD, Weynants V, Dominguez F, Barbera R, Sotolongo F. Immunogenicity and safety of three doses of a bivalent (B:4:p1.19,15 and B:4:p1.7-2,4) meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 2007 Jan;14(1):65-73. Epub 2006 Oct 25. |
| |
| Completed |
| 450 |
|
|
Inclusion Criteria:
- Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
- Female subjects must be of non-childbearing potential.
Exclusion Criteria:
- Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
|
| Both |
| 12 Years to 18 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Spain |
| |
| NCT00137917 |
|
| 710158/002 |
| GlaxoSmithKline |
|
| Study Director: |
Clinical Trials |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| November 2006 |
