A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 10 - 25 |
| Updated: | 5/5/2014 |
| Start Date: | November 2012 |
| End Date: | November 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 3, Randomized, Active Controlled, Observer Blinded Trial to Assess the Safety and Tolerability of a Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rLP2086) Vaccine Given in Healthy Subjects Aged ≥10 to <26 Years
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio
to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group
will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and
tolerability.
to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group
will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and
tolerability.
Inclusion Criteria:
- Healthy subjects aged 10 to 25 years.
Exclusion Criteria:
- Previous vaccination with Hepatitis A virus vaccine
- Previous vaccination with investigational meningococcal B vaccine
- History of culture-proven N. meningitidis serogroup B disease
- Any neuroinflammatory or autoimmune condition
- Any immune defect that would prevent an effective response to the study vaccine
We found this trial at
35
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials