A Open-label, Randomized, Multicenter Study of the Safety, Tolerability, andImmunogenicity of GARDASIL™ Given Concomitantly with REPEVAX™ in HealthyAdolescents 11-17 Years of Age

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

a. Healthy adolescent boys and girls age 11 to 17 years.

b. Must agree to provide study personnel with a primary telephone number as
well as an alternate telephone number for follow-up purposes.

c. Must agree to refrain from sexual activity throughout the course of the study
(including vaginal and anal penetration and any genital contact).

d. Subject must have been previously immunized against diphtheria, tetanus, and
pertussis (not in the last 5 years).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Individuals concurrently enrolled in clinical studies of investigational agents.

b. History of known prior vaccination with an HPV vaccine.

c. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt
of live virus vaccines within 21 days prior to enrollment.

d. Has had coitarche or plans to become sexually active through the course of the
study.

e. Temperature =100°F or =37.8°C (oral) within 24 hours prior to the first
injection

f. Pregnant now (as determined by a urine pregnancy test sensitive to 25 IU
HCG).

g. Individuals allergic to any of the vaccine components of GARDASIL™ or
REPEVAX™ or residues carried over from manufacture (such as
formaldehyde, streptomycin, neomycin, and polymoxin B). Individuals who
have experienced anaphylactic or other allergic reactions to a previous dose of
tetanus or diptheria or a component pertussis combination vaccine.
Individuals allergic to aluminum, yeast, phenoxyethanol, or BENZONASE™
(nuclease, Nycomed [used to remove residual nucleic acids from this and
other vaccines]).

i. Individuals who have received any immune globulin preparation (including
RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived products within
the 6 months prior to the first injection, or plan to receive any through the
completion of the study.

j. Individuals with a history of splenectomy, known immune disorders (e.g.,
systemic lupus erythematosus, rheumatoid arthritis), or receiving
immunosuppressives (e.g., substances or treatments known to diminish
immune response such as radiation therapy, administration of antimetabolites,
antilymphocytic sera, systemic corticosteroids). Individuals who have
received periodic treatments with immunosuppressives, defined as at least
3 courses of systemic corticosteroids each lasting at least 1 week in duration
for the year prior to enrollment, will be excluded. Subjects using topical,
inhaled or nasal steroids will be eligible for vaccination.

k. Individuals with known hemophilia, thrombocytopenia or any coagulation
disorder that would contraindicate intramuscular injections.

l. Any condition which in the opinion of the investigator might interfere with the
evaluation of the study objectives.

m. Individuals who are immunocompromised or have been diagnosed as having
HIV infection.

n. History of recent (within 1 year from the date of enrollment) or ongoing
alcohol or other drug abuse. Alcohol abusers are defined as those who drink
despite recurrent social, interpersonal, and legal problems as a result of
alcohol use.

o. Inability to give consent/assent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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