Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults

NCT00780806

Last updated date
Study Location
Pfizer Investigational Site
Herston, , QLD 4006, Australia
Contact
1-800-718-1021

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[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
18-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subject between the ages of >=18 and <=40 years

- Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.

- All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.

- Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.

- Body weight >=45 and <=120 kg.

- Able to be contacted by telephone during the study period.

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


- Pregnancy or breastfeeding women


- Prior vaccination with a serogroup B meningococcal vaccine.


- A previous anaphylactic or severe vaccine-associated adverse reaction.


- A known hypersensitivity to any study vaccine components.


- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy, including systemic corticosteroids (excluding topical, inhalation and
intra-articular corticosteroids).


- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.


- Receipt of any blood products, including gamma globulin, in the period from 6 months
before study vaccination through the study conclusion.


- Receipt of an inactivated vaccine within 14 days before study vaccinations and live
attenuated vaccine within 28 days before study vaccination. This will apply throughout
the study until the last vaccination.


- Any clinically significant chronic disease that, in the investigator's judgment may be
worsened by blood draw.


- Received any investigational drug, vaccine or device within the 30-day period before
study visit 1 and during the conduct of the study.


- History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
Official Title  ICMJE An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
Brief Summary The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE
  • Biological: meningococcal B rLP2086 vaccine candidate
    vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
  • Procedure: Blood draw
    Blood draw
Study Arms  ICMJE Experimental: 1
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
Interventions:
  • Biological: meningococcal B rLP2086 vaccine candidate
  • Procedure: Blood draw
Publications * Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, Anderson AS, Jones TR, Harris SL, Jansen KU, Perez JL. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013 Mar 15;31(12):1569-75. doi: 10.1016/j.vaccine.2013.01.021. Epub 2013 Jan 24.

*   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: October 24, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female subject between the ages of >=18 and <=40 years
  • Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
  • All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
  • Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
  • Body weight >=45 and <=120 kg.
  • Able to be contacted by telephone during the study period.

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Prior vaccination with a serogroup B meningococcal vaccine.
  • A previous anaphylactic or severe vaccine-associated adverse reaction.
  • A known hypersensitivity to any study vaccine components.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
  • Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
  • Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
  • Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
  • History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00780806
Other Study ID Numbers  ICMJE 6108A1-1003
B1971003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP