A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
- Conditions
- -B977 Papillomavirus as the cause of diseases classified to other chaptersPapillomavirus as the cause of diseases classified to other chaptersB977
- Registration Number
- PER-141-09
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• The participant is a man or a woman, between the ages of 11 years and O days and 15 years and 364 days on the day of enrollment.
• The participant is considered to have good physical health based on medical history, physical exam, and laboratory results.
• The parent / legal guardian and the participant fully understand the study procedures, the available alternative treatments, the risks involved in the study, and voluntarily agree to participate by providing their informed consent / written consent.
• The parent / legal guardian is able to read, understand and fill out the vaccination card.
• The participant agrees to provide the study staff with a primary telephone number as well as an alternative telephone number for monitoring purposes.
• The participant must not have had their sexual initiation yet and does not plan to be sexually active during the course of the study.
• The participant must have previously received a documented primary immunization series against diphtheria, tetanus and pertussis (not in the last 5 years).
• The participant has a known allergy to any vaccine component corresponding to the 9-valent VLP L1 vaccine against HPV, Menactra ™ or Adacel ™, such as aluminum, yeast or BENZONASE ™ (nuclease, Nycomed [used to eliminate nucleic acids residuals of this and other vaccines]). The participant experienced an allergy to an earlier dose of the combined tetanus or diphtheria vaccine or a component of whooping cough. For the purposes of this exclusion criteria, allergy means an allergic reaction that meets the criteria for serious adverse events as defined in Section 3.4.
• The participant has a condition that constitutes a contraindication for vaccination, as indicated in most of the updated Menactra and Adacel packaging inserts (including latex allergy).
• The participant has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
• The participant has thrombocytopenia or any clotting disorder that would contraindicate intramuscular injections.
• The participant is enrolled concurrently in clinical studies of investigating agents.
• (Girls only) - The participant is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mlU / mL of p-hCG).
• The participant has donated blood within 1 week before vaccination on Day 1, or intends to donate blood during the study.
• The participant is currently immunocompromised or has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition .
• The participant has had a splenectomy.
• The participant is receiving or has received the following immunosuppressive therapies in the year prior to enrollment: radiotherapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporine, leflunomide (Arava ™), TNF-a antagonists, monoclonal antibody therapies (such as rituximab [Rituxan]), intravenous gamma globulin (IVIG), antilymphocyte serum, or other therapy that is known to interfere with the immune response.
• The participant has received any immunoglobulin products (such as RhoGAM [Ortho-Clinical Diagnostics]) or blood products within 3 months prior to vaccination on Day 1, or plans to receive any such product during the study.
• The participant has received non-replicating (inactive) vaccines within 14 days prior to vaccination on Day 1 or has received replicating (live) vaccines within 21 days prior to vaccination on Day 1.
• The participant has received a commercial HPV vaccine, or has participated in a clinical trial with an HPV vaccine and has received either the active agent or the placebo.
• The participant has received a meningococcal vaccine.
• The participant has received a booster dose of tetanus and diphtheria toxoid (Td) (Decavac ™, Adacel ™, Boostrix ™) or tetanus toxoid (TT) within the last 5 years.
• The participant has had a fever (defined as an oral temperature> 100 ° F or> 37.8 ° C) within the 24-hour period prior to vaccination on Day 1.
• The participant has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with the intervention of the participant throughout the study, not
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.<br><br>Measure:Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503<br>Timepoints:4 weeks following Month 6 vaccination<br>
- Secondary Outcome Measures
Name Time Method