Prevention of Human Papillomavirus Infection MedDRA version: 7.0 Level: LLT Classification code 10063001
Conditions
Interventions
Product Name: GARDASIL (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine
Product Code: V501
Pharmaceutical Form: Suspension for injection
Trade Name: REPEVAX
Product Name:
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate that a first dose of REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pastuer, Swiftwater, PA U.S.A.) can be administered concomitantly with the first dose of GARDASIL™† without impairing the antibody response to HPV types 6, 11, 16, and 18, compared to the administration of GARDASIL™ alone. 2. To demonstrate that the first dose of GARDASIL™ can be administered concomitantly with a first dose of REPEVAX™ without impairing the antibody response to diphtheria, tetanus, pertussis and poliomyelitis, compared to the administration of REPEVAX™ alone. 3. To demonstrate that concomitant administration of the first dose of GARDASIL™ with REPEVAX™ will be generally well tolerated compared to when the first dose of GARDASIL™ is given separately from REPEVAX™.;Secondary Objective: To demonstrate that GARDASIL™ made in the final manufacturing facility (FMF) induces similar (noninferior) antibody responses to HPV 6, 11, 16 and 18 compared to GARDASIL™ made in the current manufacturing facility (CMF).;Primary end point(s): The primary immunogenicity endpoints for evaluating antibody response to GARDASIL™ are geometric mean titers (GMTs) to HPV 6, 11, 16, and 18 at Week 4 Postdose 3 and the percentages of subjects who seroconvert for each HPV type (6, 11, 16, and 18) by Week 4 Postdose 3. (Seroconversion is defined as changing serostatus from seronegative at baseline to seropositive by Week 4 Postdose 3, where any subject with a cLIA titer at or above the serostatus cutoff for a given HPV type is considered seropositive for that type. Previously, the anti-HPV serum cLIA cutoffs for determining serostatus were 20, 16, 20, and 24 mMU/mL for HPV types 6, 11, 16, and 18, respectively. Due to a change in the cLIA assay, these serostatus cutoffs will be updated at a later time.) The primary immunogenicity endpoints for evaluating antibody response to the diphtheria and tetanus components of | — |
Countries
Denmark, Finland, Germany
Outcome results
None listed