Vaccines Treatment Options in Ohio

The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine. Read Less

This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study. Read Less

Human 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 study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read Less

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age Read Less

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo. Read Less

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine. Read Less

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population. Read Less

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients. Read Less

This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. * Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence, * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine, * Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods. * Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: * Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. * Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose. Read Less

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine * Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period * Antiviral use. * To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2. Read Less

The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. Read Less

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group. Read Less