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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 November 10, 2019
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Study Location
Accelovance,Inc.
Huntsville, Alabama, 35802 United States
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Official Title  ICMJE 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
Brief Summary

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.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2015)		5715
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2011)		7500
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion DateSeptember 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   Germany,   Lithuania,   Poland,   Spain,   Sweden,   United States
Removed Location CountriesCanada
 
Administrative Information
NCT Number  ICMJE NCT01352793
Other Study ID Numbers  ICMJE B1971014
2009-015198-11 ( EudraCT Number )
6108A1-3003 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2015

ICMJE     Data element required by the

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

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