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

Meningitis, Meningococcal Clinical Trial

Official title:

An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780806
• Other study ID #: 6108A1-1003
• Secondary ID: B1971003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 24, 2008
• Last updated: August 22, 2011
• Start date: October 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Meningitis, Meningococcal

Intervention

Biological:
• meningococcal B rLP2086 vaccine candidate
vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months

Procedure:
• Blood draw
Blood draw

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Herston
Australia	Pfizer Investigational Site	North Adelaide
Australia	Pfizer Investigational Site	Subiaco

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to 2 years	Yes

External Links

•   To obtain contact information for a study center near you, click here.