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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

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NCT01352793

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Accelovance,Inc.
Huntsville, Alabama, 35802 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-25 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects aged 10 to 25 years.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01352793
Pfizer
Completed
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
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 Greater Than Or Equal To 10 To Less Than 26 Years

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 ?g 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Meningitis, Meningococcal
  • Biological: rLP2086 vaccine
    120 mcg, 3 doses, at month 0, 2, and 6.
  • Biological: control
    HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
  • Experimental: rLP2086 vaccine
    rLP2086 vaccine
    Intervention: Biological: rLP2086 vaccine
  • control
    The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
    Intervention: Biological: control
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5715
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 25 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   Germany,   Lithuania,   Poland,   Spain,   Sweden,   United States
Canada
 
NCT01352793
B1971014
2009-015198-11 ( EudraCT Number )
6108A1-3003 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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