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Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Miami Research Associates, Inc.
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
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
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

A subject must meet the following inclusion criteria at screening (visit 1) and at
randomization (visit 2) to be considered for enrollment in the study:

- Male or female subjects between the ages of 18 and 40.

- Healthy male or female subjects as determined by medical history, physical
examination, and judgment of the investigator.

- Male or female subject who is considered biologically capable of having children must
agree to commit to the use of a reliable method of birth control for the duration of
the study and for 30 days after early discontinuation. A subject is still biologically
capable of having children, even if he or she is using contraceptives or if his or her
sexual partner is sterile or using contraceptives.

In addition a subject must meet the following inclusion criteria at randomization (visit 2)
to be considered for enrollment in the study. The referred blood and urinalysis tests
(inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

- Female subjects of childbearing potential with a negative urine pregnancy test prior
to study drug administration. Note: this criterion will apply to each vaccination
visit and to the last study visit.

- Laboratory blood and urinalysis tests results within the per-protocol normal ranges.

- Able to be contacted by telephone during the study period. Note: this criterion will
apply to each study visit.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00879814
Pfizer
Completed
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

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Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Meningitis, Meningococcal
Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
  • Experimental: 1
    rLP2086 vaccine 60 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Experimental: 2
    rLP2086 vaccine 120 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Experimental: 3
    rLP2086 vaccine 200 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Active Comparator: 4
    Tdap vaccine - normal saline - normal saline
    Intervention: Biological: rLP2086 vaccine or control
Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:

  • Male or female subjects between the ages of 18 and 40.
  • Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
  • Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.

In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

  • Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
  • Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
  • Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00879814
6108A1-1004
B1971004 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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

BY EMAIL

Contact

[email protected]



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