
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate...
Orthomyxoviridae InfectionInfluenza1 moreAll marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). Primary Objective: To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine. Secondary Objectives: To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain. To describe the safety profile after the vaccination in each study group To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency. Observational Objectives: To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site. To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group. To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity. To evaluate the cellular mediated immune response in a subset of subjects.

Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
DNA Virus InfectionHerpesviridae Infections1 moreStudy Phase: IV Study Type: Open-label, multicenter, randomised clinical trial with two arms stratified for an intensified immunosuppressive regimen in patients at high risk for acute rejection. Study Description: 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months (Group A, prophylaxis, N=74) or received ganciclovir IV only in case of proven CMV viral load (Group B, preemptive therapy, N=74). Initially, a 2 months follow up was planned in this trial. However, the study group decided to offer a longterm follow up to all patients and amended the protocol, respectively. The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out, if one of these two strategies may increase graft or patient survival. Therefore, both wellknown approaches of CMV prevention were compared in two study groups: Prophylaxis (Group A): Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90. In case of CMV infection (proven CMV viral load) or symptomatic CMV disease, treatment with ganciclovir IV was initiated. Preemptive Therapy (Group B): No oral primary prophylaxis was given. Treatment with ganciclovir IV was given to patients with proven CMV viral load (CMV infection or CMV disease) only.

When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
HIV InfectionsAIDS-Related Opportunistic InfectionsThe purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.

Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection...
InfectionsPapillomavirusHuman Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine...
Nosocomial InfectionRespiratory Tract Infection1 moreDoes chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?

Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients...
HIV InfectionsThe purpose of this study is to compare the safety and effectiveness of an anti-HIV drug combination with and without hydroxyurea in patients with early HIV infection. Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the blood and keeping them down. However, these treatments are not effective in some patients. This study will see if using a combination containing more drugs will help in patients with early HIV infection.

Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
Cytomegalovirus InfectionsHIV InfectionsCytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in people with HIV.

Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable...
InfectionTo demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito...
Mosquito-Borne Infectious DiseasesThe purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.

Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound...
Surgical WoundSurgical Site Infection3 moreThis is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.