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OpenTrials
Completed

NCT Number: NCT00879814

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rLP2086 vaccine or control

Biological

intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months

Primary outcomes

  1. Percentage of Participants With at Least One Adverse Event (AE)

    Time frame: Baseline up to Month 7

  2. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])

    Time frame: Baseline up to Month 7

  3. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])

    Time frame: Baseline up to Month 7

  4. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)

    Time frame: Baseline up to Month 7

  5. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)

    Time frame: Baseline up to Month 7

  6. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])

    Time frame: Baseline up to Month 7

  7. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)

    Time frame: Baseline up to Month 7

  8. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])

    Time frame: Baseline up to Month 7

  9. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])

    Time frame: Baseline up to Month 7

  10. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])

    Time frame: Baseline up to Month 7

  11. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)

    Time frame: Baseline up to Month 7

  12. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)

    Time frame: Baseline up to Month 7

  13. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])

    Time frame: Baseline up to Month 7

  14. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)

    Time frame: Baseline up to Month 7

  15. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)

    Time frame: Baseline up to Month 7

  16. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)

    Time frame: Baseline up to Month 7

  17. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)

    Time frame: Baseline up to Month 7

  18. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).

    Time frame: Baseline up to Month 7

  19. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).

    Time frame: Baseline up to Month 7

  20. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).

    Time frame: Baseline up to Month 7

  21. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).

    Time frame: Baseline up to Month 7

  22. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).

    Time frame: Baseline up to Month 7

  23. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).

    Time frame: Baseline up to Month 7

  24. Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).

    Time frame: Baseline up to Month 7

Secondary outcomes

  1. Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)

    Time frame: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2009
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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