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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00780806
First received: October 24, 2008
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Meningitis, Meningococcal
Biological: meningococcal B rLP2086 vaccine candidate
Procedure: Blood draw
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780806

Locations
Australia
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
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00780806     History of Changes
Other Study ID Numbers: 6108A1-1003, B1971003
Study First Received: October 24, 2008
Last Updated: August 22, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
MnB
rLP2086
blood collection
vaccination

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014