Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
NCT00780806
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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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| 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 |
| |||
| Study Arms ICMJE | Experimental: 1
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months Interventions:
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||