We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879814
First Posted: April 13, 2009
Last Update Posted: August 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Condition Intervention Phase
Meningitis, Meningococcal Biological: rLP2086 vaccine or control Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). [ Time Frame: Baseline up to Month 7 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rLP2086 vaccine 60 mcg
Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Experimental: 2
rLP2086 vaccine 120 mcg
Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Experimental: 3
rLP2086 vaccine 200 mcg
Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Active Comparator: 4
Tdap vaccine - normal saline - normal saline
Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879814


Locations
United States, Florida
Miami Research Associates, Inc.
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00879814     History of Changes
Other Study ID Numbers: 6108A1-1004
B1971004 ( Other Identifier: Alias Study Number )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: November 17, 2014
Results First Posted: November 25, 2014
Last Update Posted: August 6, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs