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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780806
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: meningococcal B rLP2086 vaccine candidate Procedure: Blood draw Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
Study Start Date : October 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: 1
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
Biological: meningococcal B rLP2086 vaccine candidate
vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months

Procedure: Blood draw
Blood draw

Primary Outcome Measures :
  1. Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780806

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Pfizer Investigational Site
Herston, Australia, QLD 4006
Pfizer Investigational Site
North Adelaide, Australia, SA 5006
Pfizer Investigational Site
Subiaco, Australia, WA 6008
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00780806    
Other Study ID Numbers: 6108A1-1003
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
blood collection
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections