Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

Pfizer

Status and phase

Completed

Phase 1

Conditions

Meningitis, Meningococcal

Treatments

Biological: rLP2086 vaccine or control

Study type

Interventional

Funder types

Industry

Identifiers

NCT00879814

B1971004 (Other Identifier)

6108A1-1004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Enrollment

48 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:

Male or female subjects between the ages of 18 and 40.
Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.

In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.

Exclusion criteria

None

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 4 patient groups

1

Experimental group

Description:

rLP2086 vaccine 60 mcg

Treatment:

Biological: rLP2086 vaccine or control

2

Experimental group

Description:

rLP2086 vaccine 120 mcg

Treatment:

Biological: rLP2086 vaccine or control

3

Experimental group

Description:

rLP2086 vaccine 200 mcg

Treatment:

Biological: rLP2086 vaccine or control

4

Active Comparator group

Description:

Tdap vaccine - normal saline - normal saline

Treatment:

Biological: rLP2086 vaccine or control

Trial contacts and locations

1

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