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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Herston, , QLD 4006 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male or female subject between the ages of >=18 and

- 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 =13.0 and subjects.

- Blood pressure: Systolic blood pressure >90 and >60 and

- Body weight >=45 and

- Able to be contacted by telephone during the study period.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00780806
Pfizer
Completed
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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