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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00879814
First received: April 10, 2009
Last updated: November 17, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). [ Time Frame: Baseline up to Month 7 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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:

None

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Pfizer

Additional 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
Study First Received: April 10, 2009
Results First Received: November 17, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014