Clinical Trials About "Human medicines European public assessment report EPAR Gardasil" RSS

03:54 EDT 20th September 2019 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Gardasil" Clinical Trials 1–25 of 20,000+

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Human Papillomavirus (HPV) Registration Study (Gardasil)

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus types associated with increased risk of cervical cancer.

Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men

This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil) against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.


HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial

A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa.

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)

The primary purpose of the study is to determine if Gardasil (V501) an investigational vaccine with 4 components is able to prevent cervical cancer.

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix™ in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil®). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix™ or Gardasil®) according to ...

Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

Patients with immunodeficiencies are at increased risk of developing persistent HPV infection and as such HPV-related disease (genital warts and cancer). In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety, tolerability and immunogenicity will be evaluated up to one month following the 3rd and last dose of Gardasil®9.

Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

GARDASIL™ Vaccine Impact in Population Study

This study will assess the impact of GARDASIL™ in the general female population by utilizing nationwide registry databases in the participating Nordic countries.

Immunogenicity and Safety of Gardasil-9 and Cervarix

A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

The aim of the study is to assess the safety and immunogenicity of the CYD dengue vaccine when administered concomitantly or sequentially with Gardasil® (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant). Primary objectives: - To demonstrate that the humoral immune response (in terms of geometric mean titers[GMTs]) to Gardasil after concomitant administration is non-inferior to sequential administration with the CYD dengue v...

Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.

Gardasil Administration

The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.

HPV Antibody Response After GARDASIL 9 Vaccination in Participants After Allogeneic Stem Cell Transplantation

The goal of this clinical research study is to learn if Gardasil (the HPV vaccine) can prevent HPV infection and HPV-related disease when given to blood cancer patients who have received a stem cell transplant.

Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy

Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder i...

Immunogenicity of GSK Bio's HPV Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and geni...

Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India

This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen of Gardasil administered to healthy married females between 16 and 23 years of age, in India.

Gardasil Knowledge

Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of women and men who are sexually active will be exposed to a strain or strains of the virus. While there are hundreds of viral strains, high risk strains are associated cervical and oral cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were 38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to prevent infection ...

Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination

Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9 vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus, Diptheria, and Pertussis (Tdap), and meninogococcal infections6

Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™

This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.

PENTA Fosamprenavir Study

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events we...

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects

This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years. Approximately 600 subjects will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each subject received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be c...

Development of the Medicines Optimisation Assessment Tool

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.

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