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

Meningitis, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879814
• Other study ID #: 6108A1-1004
• Secondary ID: B1971004
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2009
• Last updated: July 15, 2015
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal

Intervention

Biological:
• rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
• rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
• rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
• rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months

Locations

Country	Name	City	State
United States	Miami Research Associates, Inc.	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Adverse Event (AE)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).		Baseline up to Month 7	Yes
Primary	Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).		Baseline up to Month 7	Yes
Secondary	Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)		Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3	No

External Links

•   To obtain contact information for a study center near you, click here.