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

Pfizer36 sites in 3 countries753 target enrollmentMarch 18, 2011

ConditionsMeningococcal Vaccine rLP2086 Repevax N Meningitidis Serogroup B Meningitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningococcal Vaccine
Sponsor: Pfizer
Enrollment: 753
Locations: 36
Primary Endpoint: Percentage of Participants With at Least One 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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Registry

clinicaltrials.gov

Start Date

March 18, 2011

End Date

February 19, 2013

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, 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.
•Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
•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.
•Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
•A previous anaphylactic reaction to any vaccine or vaccine-related component.
•Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
•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.

Outcomes

Primary Outcomes

Percentage of Participants With at Least One Adverse Event (AE)

Time Frame: Vaccination 1 up to 1 month after Vaccination 3

Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen

Time Frame: 1 month after Vaccination 1

Secondary Outcomes

Geometric Mean Titer (GMT) for Poliomyelitis Antigens(1 month after Vaccination 1)
Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens(1 month after Vaccination 1)
GMC for Acellular Pertussis Antigens(1 month after Vaccination 1)
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level(1 month after Vaccination 3)