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

July 15, 2015 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • Miami Research Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With at Least One Adverse Event (AE)
Time Frame: Baseline up to Month 7
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Baseline up to Month 7

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6108A1-1004
  • B1971004 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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