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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00780806




Registration number
NCT00780806
Ethics application status
Date submitted
24/10/2008
Date registered
28/10/2008
Date last updated
23/08/2011

Titles & IDs
Public title
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
Scientific title
An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
Secondary ID [1] 0 0
B1971003
Secondary ID [2] 0 0
6108A1-1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - meningococcal B rLP2086 vaccine candidate
Treatment: Surgery - Blood draw

Experimental: 1 - Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months


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

Treatment: Surgery: Blood draw
Blood draw
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [2] 0 0
Pfizer Investigational Site - North Adelaide
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
QLD 4006 - Herston
Recruitment postcode(s) [2] 0 0
SA 5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
WA 6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00780806
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00780806