A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

Pfizer46 sites in 7 countries1,714 target enrollmentMarch 3, 2011

ConditionsMeningococcal Vaccine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningococcal Vaccine
Sponsor: Pfizer
Enrollment: 1714
Locations: 46
Primary Endpoint: Percentage of Participants Reporting At Least 1 Adverse Event (AE)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Registry

clinicaltrials.gov

Start Date

March 3, 2011

End Date

September 18, 2012

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
•Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Male or female subject aged ≥11 and \<19 years at the time of enrollment.
•Available for the entire study period and can be reached by telephone.
•Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
•All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
•Negative urine pregnancy test for female subjects.

Exclusion Criteria

•Previous vaccination with any meningococcal serogroup B vaccine.
•A previous anaphylactic reaction to any vaccine or vaccine-related component.
•Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
•A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
•History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
•Significant neurological disorder or history of seizure (excluding simple febrile seizure).
•Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
•Current chronic use of systemic antibiotics.
•Participation in other studies during study participation. Participation in purely observational studies is acceptable.
•Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.

Outcomes

Primary Outcomes

Percentage of Participants Reporting At Least 1 Adverse Event (AE)

Time Frame: Injection 1 up to 1 month after Injection 4

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants

Time Frame: 1 month after Injection 4

Secondary Outcomes

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level(Before Injection 1, 1 Month after Injection 2, 3, 4)
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)(Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4)
Percentage of Participants Achieving hSBA Titer >=LLOQ(Before Injection 1, 1 Month after Injection 2, 3, 4)
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants(1 month after Injection 4)